M	FDA	C54447	Individual Case Safety Report Terminology	C53692	BREED		
N	FDA	C54447	Individual Case Safety Report Terminology	C54068	Over-the-Counter Product	A product that is available to consumers without a prescription.	
N	FDA	C54447	Individual Case Safety Report Terminology	C54696	Combination Product	(1) A product comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity; (2) Two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products; (3) A drug, device, or biological product packaged separately that according to its investigational plan or proposed labeling is intended for use only with an approved individually specified drug, device, or biological product where both are required to achieve the intended use, indication, or effect and where upon approval of the proposed product the labeling of the approved product would need to be changed, e.g., to reflect a change in intended use, dosage form, strength, route of administration, or significant change in dose; or (4) Any investigational drug, device, or biological product packaged separately that according to its proposed labeling is for use only with another individually specified investigational drug, device, or biological product where both are required to achieve the intended use, indication, or effect.	
N	FDA	C54447	Individual Case Safety Report Terminology	C93539	Reporter Confidentiality Disclosure Indicator	An indicator of whether the reporter does or does not want his/her identity disclosed to the manufacturer.	
N	FDA	C54447	Individual Case Safety Report Terminology	C99176	Pre-1938 Product	A drug product that was on the market prior to the passage of the 1938 Federal Food, Drug, and Cosmetic Act (the FD&C Act) and which contained in its labeling the same representations concerning the conditions of use as it did prior to passage of that act, was not considered a new drug and therefore was exempt from the requirement of having an approved new drug application.	
N	FDA	C88088	Observation ICSR Terminology	C17237	Food and Drug Administration		
N	FDA	C88088	Observation ICSR Terminology	C93539	Reporter Confidentiality Disclosure Indicator	An indicator of whether the reporter does or does not want his/her identity disclosed to the manufacturer.	
N	FDA	C99173	Device Evaluation ICSR Terminology	C54028	EVALUATION METHOD		
N	FDA	C99173	Device Evaluation ICSR Terminology	C54029	EVALUATION RESULT		
N	FDA	C99173	Device Evaluation ICSR Terminology	C54030	EVALUATION CONCLUSION		
N	FDA	C99174	Product Characteristic ICSR Terminology	C53629	Device Evaluated by Manufacturer		
N	FDA	C99174	Product Characteristic ICSR Terminology	C54068	Over-the-Counter Product	A product that is available to consumers without a prescription.	
N	FDA	C99174	Product Characteristic ICSR Terminology	C54696	Combination Product	(1) A product comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity; (2) Two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products; (3) A drug, device, or biological product packaged separately that according to its investigational plan or proposed labeling is intended for use only with an approved individually specified drug, device, or biological product where both are required to achieve the intended use, indication, or effect and where upon approval of the proposed product the labeling of the approved product would need to be changed, e.g., to reflect a change in intended use, dosage form, strength, route of administration, or significant change in dose; or (4) Any investigational drug, device, or biological product packaged separately that according to its proposed labeling is for use only with another individually specified investigational drug, device, or biological product where both are required to achieve the intended use, indication, or effect.	
N	FDA	C99174	Product Characteristic ICSR Terminology	C99176	Pre-1938 Product	A drug product that was on the market prior to the passage of the 1938 Federal Food, Drug, and Cosmetic Act (the FD&C Act) and which contained in its labeling the same representations concerning the conditions of use as it did prior to passage of that act, was not considered a new drug and therefore was exempt from the requirement of having an approved new drug application.	
N	FDA	C99175	Substance Administration ICSR Terminology	C53630	Concomitant Therapy