ACTIDOGESIC

Product NDC: 63102-402
11-digit product format: 631020402
Labeler code: 63102
Product ID: 63102-402_abf1349b-a08e-4236-9b32-42a0e76e78a9
Type: HUMAN OTC DRUG
Nonproprietary name: Dexbrompheniramine maleate, acetaminophen
Dosage form: TABLET
Route: ORAL
Labeler: ACTIPHARMA, LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2016-10-14
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 · 26 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63102-402-10	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63102-402-10	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63102-402-10	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63102-402-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63102-402-10	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63102-402-10	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63102-402-10	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63102-402-10	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63102-402-10	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63102-402-10	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	63102-402-10	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	63102-402-10	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	63102-402-10	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

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: ACTIDOGESIC
Listing expiration: 2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
BPA9UT29BS	Internal UNII lookup
362O9ITL9D	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
697da3f9-9888-4d41-ba83-87ca9bf1e54b	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63102-402-10	2024-08-06	C162847	48780-1	0191ceaa-6363-198a-e063-dbdaa90aec3e	ACTIDOGESIC ®
63102-402-10	2023-07-28	C162847	48780-1	0191ceaa-6363-198a-e063-dbdaa90aec3e	ACTIDOGESIC ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63102-402-10	ACTIDOGESIC	100 in 1 BOTTLE	TABLET	100		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63102-402-10	EA - Each	63102-402	7639ce03-04bd-412d-bb24-439b7f9419c4	1	2017-03-06

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 1 of 191 · 3,814 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
COLTALIN-DM	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	FORTUNE PHARMACAL COMPANY LIMITED	33e1bec0-323b-40b7-809a-cb65a71ad0ce	2026-09-17	Warnings	Exact identifier application number: M012
Cough and Cold HBP	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Geiss, Destin & Dunn Inc.	1ea07a01-8779-48c2-a287-b7be866cce7b	2026-09-10	Warnings	Exact identifier application number: M012
Childrens Cold and Allergy Relief	BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Strategic Sourcing Services LLC	d64fe757-9948-4727-b5dd-1f8e4e4763e2	2026-09-10	Warnings	Exact identifier application number: M012
Cold and Flu HBP	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE	Kroger Company	fd41e4a4-330f-4409-8ba3-0b3bb6f45bca	2026-09-10	Warnings	Exact identifier application number: M012
Nighttime Sleep Aid Berry Flavor	DIPHENHYDRAMINE HYDROCHLORIDE	Raritan Pharmaceuticals Inc	303d7651-9c8f-4a14-9f2c-7181fa0f003e	2026-09-09	Warnings	Exact identifier application number: M012
DRx Choice Fruit Punch	GUAIFENESIN	Raritan Pharmaceuticals Inc	a19d7e1c-c04e-41c6-8af6-ecde96299216	2026-09-09	Warnings	Exact identifier application number: M012
Mucus Relief Cold Flu and Sore Throat Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Raritan Pharmaceuticals Inc	2cb3e17f-3858-4773-a53f-0860ae6ff1b9	2026-09-09	Warnings	Exact identifier application number: M012
MUCINEX FAST-MAX Liquid Gels Day Night Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE	Reckitt Benckiser LLC	3856c1e4-814f-85c4-e063-6394a90ab8a8	2026-09-09	Warnings	Exact identifier application number: M012
DRx Choice Long Acting Cough	DEXTROMETHORPHAN HBR	RARITAN PHARMACEUTICALS	875b40bd-7955-4048-abbf-7f43d9ea3ac5	2026-09-09	Warnings	Exact identifier application number: M012
severe cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Rite Aid Corporation	4b8ae971-ab57-4937-a878-72d905d7b849	2026-09-09	Warnings	Exact identifier application number: M012
Cold and Flu Relief	ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	CARDINAL HEALTH 110, LLC. DBA LEADER 70000	82ba9a73-60ef-49fd-960f-5ca2bb79555e	2026-09-09	Warnings	Exact identifier application number: M012
Mucus Relief DM	DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN	The Kroger Co.	49829083-5c0a-4620-bfb3-7103642368db	2026-09-09	Warnings	Exact identifier application number: M012
DRx Choice Childrens Stuffy Nose and Chest Congestion	GUAIFENESIN AND PHENYLEPHRINE HCL	RARITAN PHARMACEUTICALS	7a3bb739-ff50-4d29-b270-d6b084906493	2026-09-09	Warnings	Exact identifier application number: M012
DRx Choice Children daytime Cough and Chest Congestion	DEXTROMETHORPHAN HBR AND GUAIFENESIN	RARITAN PHARMACEUTICALS	25fff2a6-ecb1-4117-bd11-e5ec3e3d09a9	2026-09-09	Warnings	Exact identifier application number: M012
Mucus Relief Severe Congestion and Cough Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Raritan Pharmaceuticals Inc	8a166067-b492-4742-b74c-28fac87c8d70	2026-09-09	Warnings	Exact identifier application number: M012
DRx Choice maximum strength Severe Cough plus sore throat	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	RARITAN PHARMACEUTICALS	a096cb76-0d1c-4ca8-854a-5199da0bc8f7	2026-09-09	Warnings	Exact identifier application number: M012
Vicks DayQuil VapoCOOL SEVERE COLD and FLU plus CONGESTION	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	The Procter & Gamble Manufacturing Company	efb69cc1-a745-6efc-e053-2a95a90abdc9	2026-09-08	Warnings	Exact identifier application number: M012
Vicks NyQuil VapoCOOL Severe COLD and FLU plus CONGESTION	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDE	The Procter & Gamble Manufacturing Company	efb5f0b9-9825-ab23-e053-2995a90a26ab	2026-09-08	Warnings	Exact identifier application number: M012
Vicks DayQuil and Nyquil VapoCOOL Severe COLD and FLU plus CONGESTION	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE	The Procter & Gamble Manufacturing Company	f4328b44-cdfa-41aa-e053-2995a90a2728	2026-09-08	Warnings	Exact identifier application number: M012
Vicks childrens Cough Congestion	PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, GUAIFENESIN	The Procter & Gamble Manufacturing Company	e2356457-9791-3710-e053-2995a90ad140	2026-09-08	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	697da3f9-9888-4d41-ba83-87ca9bf1e54b	5
1798453	acetaminophen 500 MG / dexbrompheniramine maleate 1 MG Oral Tablet	SCD	697da3f9-9888-4d41-ba83-87ca9bf1e54b	5
1798453	APAP 500 MG / Dexbrompheniramine maleate 1 MG Oral Tablet	SY	697da3f9-9888-4d41-ba83-87ca9bf1e54b	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63102-402-10	63102040210	100 TABLET in 1 BOTTLE (63102-402-10)	100 tablet	2016-10-14	0000-00-00	No	No	Current