Dologesic

Product NDC: 54859-001
11-digit product format: 548590001
Labeler code: 54859
Product ID: 54859-001_47460679-895d-b4d5-e063-6394a90ab919
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Dexbrompheniramine Maleate
Dosage form: TABLET
Route: ORAL
Labeler: Llorens Pharmaceutical International Division
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2016-04-01
Substance: ACETAMINOPHEN; DEXBROMPHENIRAMINE MALEATE
Active strength: 500; 1 mg/1; mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	54859-001-50	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	54859-001-01	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	54859-001-50	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	54859-001-01	`9bebd1f3094a…`	`5416666fcb17…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Dologesic
Brand name suffix: NF
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	500 mg/1
DEXBROMPHENIRAMINE MALEATE	1 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
362O9ITL9D	Internal UNII lookup
BPA9UT29BS	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1798453	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
974fc0d5-7a99-46fb-af38-b91240f728fa	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
54859-001-01	2020-12-23	Llorens-Dologesic 001
54859-001-50	2020-12-23	Llorens-Dologesic 001
54859-001-01	2020-01-31	Llorens-Dologesic 001
54859-001-50	2020-01-31	Llorens-Dologesic 001

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54859-001-01	DologesicNF	100 in 1 BOTTLE	TABLET	100		8
54859-001-50	DologesicNF	50 in 1 BOTTLE	TABLET	50		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54859-001-01	EA - Each	54859-001	00464653-486d-4552-bc14-f57535653ec8	1	2016-07-19
54859-001-50	EA - Each	54859-001	0c3d163d-a259-4fa4-bcf6-7ffa6f05d34b	1	2016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54859-001	DOLOGESIC NF (ACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATE) TABLET [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]	7	Current NDC, Legacy NDC, 2 package rows	20241225_974fc0d5-7a99-46fb-af38-b91240f728fa.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 87 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
childrens Allergy Dye Free Wal Dryl	DIPHENHYDRAMINE HYDROCHLORIDE	WALGREEN CO.	4e64e040-1662-4dc9-b33f-3e119e0b3f7b	2025-11-25	Warnings	Exact identifier application number: M012
Walgreen	NASAL	WALGREENS CO	d38f8406-d7b9-472c-a472-58968bbdb993	2025-11-25	Warnings	Exact identifier application number: M012
Theraflu Flu Relief Max Strength Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Haleon US Holdings LLC	780907b8-34ba-4ec8-bcdf-b2a31bd111df	2025-11-25	Warnings	Exact identifier application number: M012
Robitussin Elderberry Maximum Strength Cough plus Chest Congestion DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Haleon US Holdings LLC	d13efbcd-1277-45d0-8389-1ba0337f7a24	2025-11-25	Warnings	Exact identifier application number: M012
Childrens Robitussin Elderberry Cough and Chest Congestion DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Haleon US Holdings LLC	fe903448-b422-42e0-b05b-aeb3e5481e3c	2025-11-25	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	DOLGENCORP INC	1d4fcb76-22d1-7292-e063-6394a90af920	2025-11-25	Warnings	Exact identifier application number: M012
ROBITUSSIN LONG-ACTING COUGH Soft CHEWS	DEXTROMETHORPHAN HYDROBROMIDE	Haleon US Holdings LLC	f22248b7-7abd-4df7-a986-dae357ebe8f1	2025-11-25	Warnings	Exact identifier application number: M012
ROBITUSSIN Nighttime Cough DM Soft CHEWS	DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Haleon US Holdings LLC	39468746-e06d-4849-9d06-9af4d14351b0	2025-11-25	Warnings	Exact identifier application number: M012
Daytime and Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Grocery Outlet, Inc.	4478fd51-bae3-6108-e063-6394a90a07ca	2025-11-25	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	CHAIN DRUG MARKETING ASSOCIATION INC.	395bb39a-e26f-f4f2-e063-6394a90ae721	2025-11-25	Warnings	Exact identifier application number: M012
day time	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	H E B	eaf3af6a-de5b-43fe-83ff-9641646e0f6b	2025-11-25	Warnings	Exact identifier application number: M012
MUCINEX Rapid Clear Pain, Headache and Mucus Congestion and Nighttime Liquid Gels	ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	RB Health (US) LLC	38571853-992f-9998-e063-6394a90a8581	2025-11-24	Warnings	Exact identifier application number: M012
Basic Care Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Amazon.com Services LLC	e19b561c-fb76-4355-a306-d3dc46930bf2	2025-11-24	Warnings	Exact identifier application number: M012
Sinus Decongestion	PSEUDOEPHEDRINE HCL	Kroger Company	73c3a9ac-43d6-4ecd-9add-36ca1c40ba9c	2025-11-24	Warnings	Exact identifier application number: M012
Tussin Multi Symptom Cold CF	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI	Cardinal Health (Leader) 70000	14c507df-fbac-4a09-a66c-b91c2abbf550	2025-11-24	Warnings	Exact identifier application number: M012
Severe Nighttime Cold and Flu Relief	ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE PHENYLEPHRINE HCI	Family Dollar (FAMILY WELLNESS)	e5c90d6e-70aa-4886-bc81-293e0dcf5638	2025-11-24	Warnings	Exact identifier application number: M012
Throat Coat Eucalyptus Mint	MENTHOL	Traditional Medicinals, Inc.	a7a86f1b-30e8-6f5d-e053-2a95a90a2a82	2025-11-21	Warnings	Exact identifier application number: M012
Throat Coat Sweet Orange Fennel	MENTHOL	Traditional Medicinals, Inc.	4538248f-11cc-d6b2-e063-6294a90a652c	2025-11-21	Warnings	Exact identifier application number: M012
up and up Daytime Nighttime Childrens Multi Symptom Cold	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Target Corporation	b8a4da0b-e4d3-48e6-b699-cb56c7b67ed7	2025-11-20	Warnings	Exact identifier application number: M012
Supress DX Pediatric Drops	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	KRAMER NOVIS	ddb95436-7806-4086-af4d-18a6625b5c83	2025-11-20	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
BPA9UT29BS	DEXBROMPHENIRAMINE MALEATE	2391-03-9	DEXBROMPHENIRAMINE MALEATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1798453	acetaminophen 500 MG / dexbrompheniramine maleate 1 MG Oral Tablet	PSN	974fc0d5-7a99-46fb-af38-b91240f728fa	8
1798453	acetaminophen 500 MG / dexbrompheniramine maleate 1 MG Oral Tablet	SCD	974fc0d5-7a99-46fb-af38-b91240f728fa	8
1798453	APAP 500 MG / Dexbrompheniramine maleate 1 MG Oral Tablet	SY	974fc0d5-7a99-46fb-af38-b91240f728fa	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54859-001-01	54859000101	100 TABLET in 1 BOTTLE (54859-001-01)	100 tablet	2016-04-01	0000-00-00	No	No	Current
54859-001-50	54859000150	50 TABLET in 1 BOTTLE (54859-001-50)	50 tablet	2016-04-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Llorens-Dologesic 001	Llorens Pharmaceutical International Division	2025-12-31	HUMAN OTC DRUG LABEL	8