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 137 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Effervescent Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHYLEPHRINE BITARTRATE	Topco Associates LLC	a2929bcb-fa81-4f15-b087-a9996b5e7d1f	2024-11-13	Warnings	Exact identifier application number: M012
Equate Effervescent Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Walmart	6271bb48-74b2-eb57-e053-2991aa0afd1b	2024-11-13	Warnings	Exact identifier application number: M012
Equaline Effervescent Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	United Natural Foods, Inc. dba UNFI	6bf341e0-94b1-08ff-e053-2991aa0af634	2024-11-13	Warnings	Exact identifier application number: M012
Good Sense Effervescent Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Good Sense	cd25e250-bb8b-7e83-e053-2a95a90a2639	2024-11-13	Warnings	Exact identifier application number: M012
Top Value Effervescent Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Tower Laboratories Ltd	440a00b1-7960-0cc4-e054-00144ff8d46c	2024-11-13	Warnings	Exact identifier application number: M012
Top Value Effervescent Cold Relief - Orange	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Tower Laboratories Ltd.	c6f207e8-bc0d-853a-e053-2a95a90ac623	2024-11-13	Warnings	Exact identifier application number: M012
Effervescent Orange Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	DOLGENCORP, LLC	7fad8e65-34fe-5313-e053-2a91aa0a56f4	2024-11-13	Warnings	Exact identifier application number: M012
Dollar General Effervescent Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHYLEPHRINE BITARTRATE	DOLGENCORP, LLC	7face5c7-f5c7-7eee-e053-2991aa0ab064	2024-11-13	Warnings	Exact identifier application number: M012
Quality Choice Effervescent Cold Relief Plus	ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE	Chain Drug Marketing Association	90622927-9682-4eb0-8c7f-894230b3dda4	2024-11-13	Warnings	Exact identifier application number: M012
Quality Choice Effervescent Cold Relief - Orange	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Chain Drug Marketing Association	9f7d76f0-4f1c-a1c7-e053-2a95a90a3dca	2024-11-13	Warnings	Exact identifier application number: M012
WinCo Foods Effervescent Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE	WinCo Foods, LLC	d443a030-d3d6-40e0-8fe0-329de6bc494f	2024-11-13	Warnings	Exact identifier application number: M012
careone tussin dm	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	American Sales Company	954fe703-9a10-4354-8b71-4d98a22a0b9f	2024-11-13	Warnings	Exact identifier application number: M012
NASAL DECONGESTANT PE	PHENYLEPHRINE HCL	A-S Medication Solutions	9d030767-dfd6-48b4-9b17-4e20c23915f3	2024-11-13	Warnings	Exact identifier application number: M012
Childrens SUDAFED PE Cold plus Cough	DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	20e45243-3989-413a-bcf1-49d754ff2e44	2024-11-12	Warnings	Exact identifier application number: M012
Tukol Cough And Cold Honey Flavor	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Genomma Lab USA	a4b333dc-58da-45db-87b6-6fcb8fb542b8	2024-11-12	Warnings	Exact identifier application number: M012
daytime nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Walgreen Company	4b49137c-8fc9-43b7-b1a1-82e318237eb6	2024-11-12	Warnings	Exact identifier application number: M012
CVS Original Nasal Mist	OXYMETAZOLINE HCL	CVS PHARMACY, INC	e9c551a0-cd78-4272-b42f-36c096d26736	2024-11-12	Warnings	Exact identifier application number: M012
up and up cough plus chest congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN	Target Corporation	ed5dfeb1-8f7a-46ff-ae27-3fa5de5b397c	2024-11-12	Warnings	Exact identifier application number: M012
DG Health Cold and Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Dolgencorp Inc	b33d104b-0b4d-40c6-8345-c2c740327331	2024-11-11	Warnings	Exact identifier application number: M012
Zephrex D	PSEUDOEPHEDRINE HYDROCHLORIDE	L. Perrigo Company	5468a7e2-361b-494f-9ca3-1b62f3819f65	2024-11-11	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