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 113 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allergy Relief Diphenhydramine HCl 25mg SoftGel	DIPHENHYDRAMINE HYDROCHLORIDE	NUVICARE LLC	bb728ceb-8eb0-4192-a8b0-742756819a05	2025-06-26	Warnings	Exact identifier application number: M012
ALLERGY RELIEF	DIPHENHYDRAMINE HYDROCHLORIDE	TIME CAP LABORATORIES, INC	7aee34b5-1583-4a8a-8ffb-b17ef2722ac1	2025-06-25	Warnings	Exact identifier application number: M012
ALLERGY RELIEF	DIPHENHYDRAMINE HYDROCHLORIDE	WALGREENS	c0270298-e7c5-e500-e053-2995a90aed23	2025-06-25	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Walmart Inc.	24ff91f2-02db-56a2-e063-6394a90a31c9	2025-06-25	Warnings	Exact identifier application number: M012
Cough and Chest Congestion Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN	Genexa Inc.	e920b700-30d3-3266-e053-2a95a90a0639	2025-06-24	Warnings	Exact identifier application number: M012
good sense childrens cold cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	L. Perrigo Company	2ffe0fbc-236d-417b-bbfd-5b9294f3c90a	2025-06-23	Warnings	Exact identifier application number: M012
Exchange Select Cough Drop Black Cherry Sugar Free	MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	38034ad2-5eab-9caf-e063-6294a90abb8f	2025-06-20	Warnings	Exact identifier application number: M012
Herbal Cough Drops	HERBAL MENTHOL	Meijer, Inc.	380364be-4e52-fa52-e063-6394a90a713c	2025-06-20	Warnings	Exact identifier application number: M012
DayQuil Cold and Flu w/VapoCOOL, 4ct (PE-free), BSX	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE TABLET, COATED	Lil' Drug Store Products, Inc.	37c55543-e05e-2f7c-e063-6394a90a4534	2025-06-20	Warnings	Exact identifier application number: M012
Exchange Select Cough Drops Honey Lemon Sugar-Free	MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	38049d29-f47e-9478-e063-6294a90aa2a4	2025-06-20	Warnings	Exact identifier application number: M012
Exchange Select Cough Drops Menthol Sugar Free	MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	3804a271-9a11-848d-e063-6394a90af87d	2025-06-20	Warnings	Exact identifier application number: M012
Exchange Select Cough Drops Menthol Sugar Free	MENTHOL	Army & Air Force Exchange Service	3805ef07-247d-0df7-e063-6394a90ac45b	2025-06-20	Warnings	Exact identifier application number: M012
Exchange Select Cough Drop Black Cherry Sugar Free	MENTHOL	Army & Air Force Exchange Service	3805f8f5-562f-0ba8-e063-6394a90ac9d9	2025-06-20	Warnings	Exact identifier application number: M012
Exchange Select Cough Drops Honey Lemon Sugar-Free	MENTHOL	Army & Air Force Exchange Service	3805f90e-bd89-128d-e063-6394a90afa01	2025-06-20	Warnings	Exact identifier application number: M012
TARGET Multi Symptom Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	TARGET CORPORATION	aebe3c15-53ef-46ea-af39-8c9b8114595f	2025-06-20	Warnings	Exact identifier application number: M012
TYLENOL Cold Plus Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Morning Star OTC	be95332d-a2e0-42e8-bfb3-8850d74990ff	2025-06-19	Warnings	Exact identifier application number: M012
Tylenol Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Morning Star OTC	37e939c6-064b-3548-e063-6294a90a337d	2025-06-19	Warnings	Exact identifier application number: M012
Capron DM	DEXTROMETHORPHAN HBR AND PYRILAMINE MALEATE	Capital Pharmaceutical, LLC	cf778c5f-475e-4a86-a87c-2be1e665f5a5	2025-06-18	Warnings	Exact identifier application number: M012
Cough Out	GUAIFENESIN	Efficient Laboratories Inc.	fe4c3921-8d30-4cd6-ba90-9211b362a38a	2025-06-18	Warnings	Exact identifier application number: M012
Guaifenesin STRAWBERRY-BANANA FLAVOR	GUAIFENESIN	Innovida Pharmaeutique Corporation	1006906e-d6d7-4f49-92bf-3cb2d2cdbb16	2025-06-18	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