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 142 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Foster and Thrive Adult Tussin DM MAX	DEXTROMETHORPHAN HBR, GUAIFENESIN	Strategic Sourcing Services LLC	5f6e4d56-4a66-4dbd-97c8-550310dea358	2024-11-05	Warnings	Exact identifier application number: M012
Cough Drops Honey Lemon with Sugar	MENTHOL	Lidl US LLC	4ad9398f-7488-6eaf-e054-00144ff8d46c	2024-11-05	Warnings	Exact identifier application number: M012
rexall dm cough and congestion relief	DEXTROMETHORPHAN HBR, GUAIFENESIN	Dolgencorp, LLC	906838b1-a742-4728-944d-42b687b8cd59	2024-11-05	Warnings	Exact identifier application number: M012
tussin	DEXTROMETHORPHAN HBR, GUAIFENESIN	H E B	7c24c59c-7549-4c64-95f8-4bf755cd6f61	2024-11-05	Warnings	Exact identifier application number: M012
equate adult tussin dm max	DEXTROMETHORPHAN HBR, GUAIFENESIN	Wal-Mart Stores Inc	3592e000-a6c6-47fe-8bb0-9341c65c2959	2024-11-05	Warnings	Exact identifier application number: M012
tussin dm max	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Walgreen Company	756794b0-8d3b-4732-947c-a407caf400e2	2024-11-05	Warnings	Exact identifier application number: M012
basic care tussin dm max	DEXTROMETHORPHAN HBR, GUAIFENESIN	Amazon.com Services LLC	c6863e31-e1b9-40ff-ae2e-4aec86b4acc0	2024-11-05	Warnings	Exact identifier application number: M012
topcare tussin dm max	DEXTROMETHORPHAN HBR, GUAIFENESIN	Topco Associates LLC	94c35025-7bb4-4cb0-8bf3-4b44bb7fa59a	2024-11-05	Warnings	Exact identifier application number: M012
Childrens Sudafed PE NASAL DECONGESTANT	PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	4dfd46e4-b9f9-464d-aa47-e8fa9e526a5d	2024-11-04	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Safeway, Inc.	164b2559-2d3f-431e-a03c-07e86731af5c	2024-11-04	Warnings	Exact identifier application number: M012
tussin severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	H E B	7cc2c136-d1b7-4658-99bb-73bb1d140261	2024-11-04	Warnings	Exact identifier application number: M012
dg health tussin	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Dolgencorp Inc	a5d0ee70-d528-4a53-bf01-7bb13b364ed0	2024-11-04	Warnings	Exact identifier application number: M012
basic care tussin cf severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Amazon.com Services LLC	bba9a17d-eb87-46f3-acee-c9dd34e5bfd4	2024-11-04	Warnings	Exact identifier application number: M012
topcare tussin cf max	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	b553b7e6-933b-49e3-97d3-22a4643a04b9	2024-11-04	Warnings	Exact identifier application number: M012
dg health nasal original	OXYMETAZOLINE HYDROCHLORIDE	Dolgencorp, LLC	fb209752-705a-4bb0-9298-8b70357f3911	2024-11-02	Warnings	Exact identifier application number: M012
nasal	OXYMETAZOLINE HYDROCHLORIDE	H E B	3c301993-642a-487c-96a2-ebc4ef90dc88	2024-11-02	Warnings	Exact identifier application number: M012
basic care nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Amazon.com Services LLC	1341744c-43c3-462b-b93c-1e46476fd935	2024-11-01	Warnings	Exact identifier application number: M012
Nighttime Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	CVS Pharmacy	43784616-1afd-4ff7-8fee-6ac389f616a2	2024-11-01	Warnings	Exact identifier application number: M012
topcare nite time cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Topco Associates LLC	28ef87e8-29e5-444d-b1f7-5c38a7f758d3	2024-11-01	Warnings	Exact identifier application number: M012
Good Sense Severe NightTime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	L. Perrigo Company	0e3c36c9-d45b-41b9-891d-a42d854295f9	2024-11-01	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