Cold and Flu

Product NDC: 55315-066
11-digit product format: 553150066
Labeler code: 55315
Product ID: 55315-066_98097347-e488-4acd-9bc1-d50a4d0eb7fe
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
Dosage form: LIQUID
Route: ORAL
Labeler: Freds Inc
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2015-07-31
Marketing end: 0000-00-00
Substance: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 325 mg/15mL; mg/15mL; mg/15mL
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55315-066-12	2023-01-30	C162847	48780-1	d6a99b39-eba8-a426-e053-dadaa90af4c2	50b08d7f-983c-4e87-8f7f-7bc4c99ab703
55315-066-12	2022-01-28	C162847	48780-1	d6a99b39-eba8-a426-e053-dadaa90af4c2	50b08d7f-983c-4e87-8f7f-7bc4c99ab703

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55315-066-12	55315006612	355 mL in 1 BOTTLE, PLASTIC (55315-066-12)	355 ml	2015-07-31	0000-00-00	No	No	Current