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 65 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allergy Relief Dye Free	DIPHENHYDRAMINE HYDROCHLORIDE 25MG	Walgreens	36ba3ff2-1965-aa56-e063-6294a90afe17	2025-12-31	Warnings	Exact identifier application number: M012
Sinus Congestion and Pain Severe	ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL	Wal-Mart Stores Inc	f51d1d52-39c2-4259-8b30-f9ac21edb265	2025-12-31	Warnings	Exact identifier application number: M012
Durahist	DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL	Poly Pharmaceuticals, Inc.	33d71863-5cac-669f-e063-6394a90a6f21	2025-12-30	Warnings	Exact identifier application number: M012
Chest Congestion Relief	GUAIFENESIN	RUGBY LABORATORIES	51b088bc-b44f-44b9-a08e-133509a35a2c	2025-12-30	Warnings	Exact identifier application number: M012
Chest Congestion Relief DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	RUGBY LABORATORIES	60c9e493-f58c-45d6-bade-c95297512403	2025-12-30	Warnings	Exact identifier application number: M012
BIO-RYTUSS	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Advanced Generic Corporation	e48e46e3-d3fa-4b25-8b07-bbecc4f0b64b	2025-12-30	Warnings	Exact identifier application number: M012
Altituss	DEXTROMETHORPHAN HBR, GUAIFENESIN	Alternative Pharmacal Corporation	e4ac96f5-2a3a-42a8-8db5-80de4dcdbd44	2025-12-30	Warnings	Exact identifier application number: M012
Biocof	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HCL	Advanced Generic Corporation	6ae6a0cb-b4fc-4e7d-aefc-6a52ca1ae3d6	2025-12-30	Warnings	Exact identifier application number: M012
Altipres Pediatric	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Advanced Generic Corporation	2a336896-a2f8-2a0c-e063-6294a90ae03a	2025-12-30	Warnings	Exact identifier application number: M012
Altipres	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Alternative Pharmacal Corporation	c5a43107-3eb8-46bb-87bd-20deafe28c3f	2025-12-30	Warnings	Exact identifier application number: M012
Mucus Relief DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Chain Drug Marketing Association, Inc.	d02f32c1-716e-4753-abba-ff97c4dc9e22	2025-12-30	Warnings	Exact identifier application number: M012
NIGHTTIME SEVERE COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	KROGER	a690f5c5-ff41-4072-e053-2995a90a8e55	2025-12-29	Warnings	Exact identifier application number: M012
Ninjacof	CHLOPHEDIANOL HCL AND PYRILAMINE MALEATE	Centurion Labs, LLC	e2bca40f-9c27-ec8b-2ff0-ef9847ba2037	2025-12-29	Warnings	Exact identifier application number: M012
QUALITY CHOICE	COUGH DROPS CHERRY	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	23079194-b5e7-d5e6-e063-6394a90a4d8c	2025-12-29	Warnings	Exact identifier application number: M012
QUALITY CHOICE	COUGH DROPS HONEY LEMON	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	2307db15-592b-138a-e063-6394a90a23a5	2025-12-29	Warnings	Exact identifier application number: M012
QUALITY CHOICE Cough Drops Vanilla Honey	COUGH DROPS VANILLA HONEY	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	23087ee3-26a0-e2b8-e063-6394a90abef4	2025-12-29	Warnings	Exact identifier application number: M012
QUALITY CHOICE Cough Drops Black Cherry SUGAR FREE	COUGH DROPS BLACK CHERRY SUGAR FREE	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	230883da-de48-68e9-e063-6394a90a927c	2025-12-29	Warnings	Exact identifier application number: M012
QUALITY CHOICE	COUGH DROPS VITAMIN C	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	23086723-5718-6d02-e063-6394a90a03d2	2025-12-29	Warnings	Exact identifier application number: M012
QUALITY CHOICE Cough Drops Creamy Strawberry	COUGH DROPS CREAMY STRAWBERRY	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	23085717-b2ee-175c-e063-6394a90a7f54	2025-12-29	Warnings	Exact identifier application number: M012
QUALITY CHOICE	COUGH DROPS MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	2307bbe9-7c8f-4eff-e063-6394a90af4c3	2025-12-29	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