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 124 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alka-Seltzer Plus Multi-Symptom Cold and Flu Day and Night Liquid Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Bayer HealthCare LLC.	34b2e77f-5d04-15a7-e054-00144ff8d46c	2025-01-17	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Severe Cold PowerFast Fizz Orange Zest	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	a23a6db6-4585-2882-e053-2a95a90ab01a	2025-01-17	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Severe Cold Night PowerFast Fizz	ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	fc754dff-cecd-fc6b-e053-6394a90ab371	2025-01-17	Warnings	Exact identifier application number: M012
Kroger DayTime Cold and Flu SOFTGEL	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	The Kroger Co.	2499210b-c162-76b9-e063-6294a90adbc3	2025-01-17	Warnings	Exact identifier application number: M012
Childrens Multi Symptom Cold Very Berry	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	CVS	2a849ae9-338f-4642-e063-6394a90a1ca4	2025-01-17	Warnings	Exact identifier application number: M012
Kroger NightTime Cold and Flu SOFTGEL	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	The Kroger Co.	24a73de3-e9eb-4cd4-e063-6394a90aa263	2025-01-17	Warnings	Exact identifier application number: M012
Diphenhydramine HCl Oral Solution	DIPHENHYDRAMINE HCL ORAL	Everpharm LLC	d7aaf874-69ac-49cf-93be-6d4a38b9a557	2025-01-16	Warnings	Exact identifier application number: M012
Cough Relief	DEXTROMETHORPHAN HBR	Best Choice (Valu Merchandisers Company)	204a7fc4-142d-45fd-8a77-0612857132be	2025-01-16	Warnings	Exact identifier application number: M012
daytime cold and flu nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE	Meijer, Inc.	df31056b-d0eb-4094-98d9-3d444210d50d	2025-01-16	Warnings	Exact identifier application number: M012
Childrens Ibuprofen Oral Suspension	IBUPROFEN	Reliable 1 Laboratories LLC	28dd9baa-43bd-b60a-e063-6394a90a8cf7	2025-01-15	Warnings	Exact identifier application number: M012
Guaifenesin	GUAIFENESIN	Reliable 1 Laboratories LLC	ae469d4f-91c4-cff0-e053-2995a90a0497	2025-01-15	Warnings	Exact identifier application number: M012
Diphenhydramine HCL 25 mg	DIPHENHYDRAMINE HCL	Reliable 1 Laboratories LLC	32f58cb3-941f-263b-e054-00144ff8d46c	2025-01-15	Warnings	Exact identifier application number: M012
Diphenhydramine HCl 25 mg	DIPHENHYDRAMINE HCL	Reliable 1 Laboratories LLC	32fa40ad-fed5-586f-e054-00144ff88e88	2025-01-15	Warnings	Exact identifier application number: M012
CVS Health Chest Congestion and Cough HBP SOFTGEL	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	CVS Pharmacy, Inc	2741ba44-1cc7-1812-e063-6394a90a8faa	2025-01-14	Warnings	Exact identifier application number: M012
DAY COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	TARGET CORPORATION	2b941963-8a8c-4148-e063-6294a90a1dfb	2025-01-13	Warnings	Exact identifier application number: M012
Diphenhydramine HCL	DIPHENHYDRAMINE HCL	SDA Laboratories, Inc.	437e6a13-a4ff-4f98-8973-042f224ee85e	2025-01-13	Warnings	Exact identifier application number: M012
Diphenhydramine HCL	DIPHENHYDRAMINE HCL	SDA Laboratories, Inc.	6a520986-1004-4ee6-9a47-1dfd90bb1b2c	2025-01-13	Warnings	Exact identifier application number: M012
good sense daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	L. Perrigo Company	5ddf3283-94e4-465d-842a-471ee946c330	2025-01-10	Warnings	Exact identifier application number: M012
Vicks VapoSteam	CAMPHOR (SYNTHETIC)	Kaz USA, Inc	c28da455-07ad-4053-8b9e-fc559f9a3f72	2025-01-10	Warnings	Exact identifier application number: M012
Guaifenesin 200mg	GUAIFENESIN	Aphena Pharma Solutions - Tennessee, LLC	45ac210a-8c54-4469-8e10-e6fe52b89cb5	2025-01-09	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