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 56 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Seacall Nasal Spray.	NASAL SPRAY	Guangdong Quadrant Ecological Technology Co., Ltd.	1f12618b-7461-fb47-e063-6294a90af753	2026-01-23	Warnings	Exact identifier application number: M012
daytime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	ecf7d210-102c-4053-81f6-67116de6cf7b	2026-01-23	Warnings	Exact identifier application number: M012
Good Neighbor Pharmacy Day Time	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Amerisource Bergen	44f9255b-0bf9-4573-ac9c-410acb515bc2	2026-01-23	Warnings	Exact identifier application number: M012
Daytime cold and flu non drowsy	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Meijer Distribution Inc	29caa3a7-7fe6-4134-a9b0-49bdb9280ca7	2026-01-23	Warnings	Exact identifier application number: M012
good neighbor pharmacy night time	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Amerisource Bergen	e2b5c27e-ca5f-4503-a3ce-c86e1d8070a7	2026-01-23	Warnings	Exact identifier application number: M012
RAYO ACTIVE ICE	MENTHOL, CAMPHOR	Quimicas Handal de Centroamerica SA de CV	09e4a36b-020a-c5b1-e063-6394a90a3e31	2026-01-22	Warnings	Exact identifier application number: M012
DRX CHOICE NIGHTTIME COLD and FLU RELIEF	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE	Raritan Pharmaceuticals Inc.	f466fc0e-3384-4884-832e-99bf1fdcf899	2026-01-21	Warnings	Exact identifier application number: M012
Tussin DM	DEXTROMETHORPHAN HBR GUAIFENESIN	Strategic Sourcing Services LLC	84750bfb-9e94-40a3-b731-21799f5e4fd1	2026-01-20	Warnings	Exact identifier application number: M012
Cough and Cold HBP	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Amerisource Bergen	0b58990f-2246-408e-9365-51f56bb6766c	2026-01-20	Warnings	Exact identifier application number: M012
NightTime Cold and Flu Multi Symptom	ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DOXYLAMINE SUCCINATE	CARDINAL HEALTH 110, LLC. DBA LEADER 70000	a8460fc9-2d08-4e5f-8dd3-5135ecda5923	2026-01-20	Warnings	Exact identifier application number: M012
Mucus Relief DM Max	DEXTROMETHORPHAN HBR, GUAIFENESIN	Family Dollar Services Inc	0a651316-623e-41eb-ab3a-641f5d807425	2026-01-20	Warnings	Exact identifier application number: M012
Walgreens Maximum Strength Non Drowsy Day and Night Cold and Flu	WALGREENS MAXIMUM STRENGTH NON DROWSY DAY AND NIGHT COLD AND FLU	Walgreens	579c47c8-6366-4785-9680-d3986ce9641d	2026-01-19	Warnings	Exact identifier application number: M012
Walgreens Maximum Strength Non-Drowsy Day and Night Sinus and Cold	WALGREENS MAXIMUM STRENGTH NON-DROWSY DAY AND NIGHT SINUS AND COLD	Walgreens	dd61c9d3-0b70-450e-9525-282710b383cc	2026-01-19	Warnings	Exact identifier application number: M012
Sinus Severe Ultra Fine Mist	OXYMETAZOLINE HYDROCHLORIDE.	VIVUNT PHARMA LLC	48bf7422-38ef-d4b4-e063-6294a90aa3ab	2026-01-19	Warnings	Exact identifier application number: M012
Cold and Flu Daytime, Nighttime, Multi-Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Walgreens	fc670515-a820-4ea7-8786-8ae710798b31	2026-01-19	Warnings	Exact identifier application number: M012
Allergy Relief Dye Free	DIPHENHYDRAMINE HCL	WALGREENS	9dece7b1-00b1-2499-e053-2a95a90a0be3	2026-01-19	Warnings	Exact identifier application number: M012
SEVERE COLD AND FLU DAYTIME NON DROWSY and NIGHTTIME	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE,GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE / ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Walgreens	2dba2bec-e0e3-4910-89c5-ebc093e05bec	2026-01-19	Warnings	Exact identifier application number: M012
SEVERE DAYTIME COLD and FLU DAYTIME MAXIMUM STRENGTH NON-DROWSY SEVERE	ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Walgreens	ca3c1eb4-6099-5e5f-e053-2995a90ab61b	2026-01-19	Warnings	Exact identifier application number: M012
SEVERE NIGHTTIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE	WALGREENS	fe6dff90-18f1-491e-84b9-cc74bb1831ba	2026-01-19	Warnings	Exact identifier application number: M012
Daytime Non-Drowsy Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Walgreens Company	ec8c73d5-b190-432a-92c6-68ea0fc86ea6	2026-01-19	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