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: DEXBROMPHENIRAMINE MALEATE; ACETAMINOPHEN
Active strength: 1; 500 mg/1; mg/1
NDC exclude flag: No
Listing certified through: 2027-12-31
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: 2027-12-31

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 20 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Health Pharma USA LLC	319e84fd-4033-f5eb-e063-6394a90aa2f3	2026-06-27	Warnings	Exact identifier application number: M012
HyVee Cough Drops Menthol	MENTHOL	HY-VEE, INC	47a6f3c3-a6fa-dd61-e063-6394a90a4965	2026-06-26	Warnings	Exact identifier application number: M012
HyVee Cough Drops Cherry	MENTHOL	HY-VEE, INC	47a717e9-56b3-e771-e063-6394a90a5c17	2026-06-26	Warnings	Exact identifier application number: M012
Calmco Allergy Relief	DIPHENHYDRAMINE HCL	CalmCo LLC	5532fd37-cdd6-97ab-e063-6394a90a3c77	2026-06-26	Warnings	Exact identifier application number: M012
Dr Kids Allergy Relief	DIPHENHYDRAMINE HCL	CalmCo LLC	5533e705-b8d5-71cf-e063-6394a90a2010	2026-06-26	Warnings	Exact identifier application number: M012
Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE	HHH Pharmaceuticals	265f1ce7-160c-4dda-b2e0-b78d68f962bd	2026-06-26	Warnings	Exact identifier application number: M012
Allergy Relief	CHLORPHENIRAMINE MALEATE	Bryant Ranch Prepack	ee052b39-1658-4071-b081-5433c87b5e4a	2026-06-25	Warnings	Exact identifier application number: M012
Allergy Multi-Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL	DOLGENCORP, LLC	fae1499a-7029-4208-8436-4d330347b915	2026-06-25	Warnings	Exact identifier application number: M012
Sinus Pressure and Pain Maximum Strength	ACETAMINOPHEN, PHENYLEPHRINE HCL	DOLGENCORP, LLC	4fe8f124-ac80-40b4-8e1d-96709c459a4f	2026-06-25	Warnings	Exact identifier application number: M012
Allergy and Sinus Headache	ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL	ARMY AND AIR FORCE EXCHANGE SERVICE	91268cd0-c151-4744-a715-a57af3f3a314	2026-06-25	Warnings	Exact identifier application number: M012
Cold and Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Meijer Distribution, Inc.	a3c4b9c3-bdb1-4f79-bee6-1bb6bec215ea	2026-06-24	Warnings	Exact identifier application number: M012
Cold and Flu Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	ARMY AND AIR FORCE EXCHANGE SERVICE	cb475e7f-aec1-415d-9770-07cce4e02c07	2026-06-24	Warnings	Exact identifier application number: M012
Broncolito Children	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Pharmadel LLC	509f5b72-9894-ef44-e063-6394a90a6d07	2026-06-23	Warnings	Exact identifier application number: M012
Neo-Synephrine Severe	PHENYLEPHRINE HYDROCHLORIDE	BF ASCHER AND CO INC	54edaff7-d241-dc90-e063-6294a90ac64d	2026-06-23	Warnings	Exact identifier application number: M012
AXIV Sinus Severe Ultra Fine Mist	OXYMETAZOLINE HYDROCHLORIDE.	VIVUNT PHARMA LLC	4b81abf9-3ea7-e996-e063-6394a90a71e8	2026-06-23	Warnings	Exact identifier application number: M012
AXIV Sinus OVERNIGHT	OXYMETAZOLINE HYDROCHLORIDE.	VIVUNT PHARMA LLC	54e03a63-f978-33d4-e063-6394a90a30f2	2026-06-23	Warnings	Exact identifier application number: M012
equaline daytime cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	9a199782-5d7e-449b-a86c-969746f0e96f	2026-06-23	Warnings	Exact identifier application number: M012
Cough and Cold HBP	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Walgreen Company	542b9861-8055-45f6-8cbf-9fe5cde1c4d9	2026-06-23	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	BIONPHARMA INC.	3c1953a1-32e9-6c81-e063-6294a90a9fa2	2026-06-22	Warnings	Exact identifier application number: M012
DAYTIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	59db2573-7ebb-4cf9-bfe3-428929bb4eeb	2026-06-22	Warnings	Exact identifier application number: M012

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

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