Percogesic

Product NDC: 63029-053
11-digit product format: 630290053
Labeler code: 63029
Product ID: 63029-053_6a927a49-32fc-4139-b0fe-7d2520495273
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen and Diphenhydramine HCl
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Medtech Products Inc.
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2010-03-19
Substance: ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 325; 12.5 mg/1; mg/1
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	63029-053	63029-053-24	D	Discontinued by firm		2026-10-23
excluded package	package	63029-053	63029-053-50	D	Discontinued by firm		2026-10-23

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 · 16 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	63029-053-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	63029-053-24	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	63029-053-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	63029-053-24	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	63029-053-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	63029-053-24	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	63029-053-50	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	63029-053-24	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	63029-053-50	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	63029-053-24	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	63029-053-50	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	63029-053-24	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	63029-053-50	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	63029-053-24	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	63029-053-50	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	63029-053-24	`ed331223b511…`	`672a5bd82f5f…`

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: Percogesic
Brand name suffix: Original Strength
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	325 mg/1
DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
362O9ITL9D	Internal UNII lookup
TC2D6JAD40	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1052462	Internal RxNorm lookup
1052466	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
529974c2-0121-4892-8e47-c2c447581091	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
75d4bef7-334c-4a95-abb5-bff9def24114	Product name	2	20260112
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
7dea7767-9f52-b60a-5435-33cb9cc28bae	Product name	4	20250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4	Product name	7	20250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7f	Product name	5	20250115
0ca83774-3f79-b837-5d6f-c210102f3bc8	Product name	6	20250114
88300afc-e1c4-ad17-c80b-4957f1b809a5	Product name	5	20250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043	Product name	7	20240611
16cde546-8deb-4df2-a072-dab5566ede95	Product name	1	20231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66f	Product name	1	20230808
a3631b20-02d1-41d7-8187-5e5e850b9e80	Product name	1	20230306
79e1734e-f721-4d46-978a-be382f771672	Product name	2	20230110
41b814f3-0166-1c53-c9ef-a0794c7daf9d	Product name	3	20221110
a590be26-846c-8659-a5a1-fb25907965dc	Product name	2	20221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6	Product name	9	20220921
92ead9ae-674d-4eee-a492-c385d496891f	Product name	3	20220308
103b151b-b17f-42ac-8624-3ef62f5e2975	Product name	2	20200507
b8497372-efe9-9dde-fa2d-59be9761aa64	Product name	9	20200428
20c8cafe-5cfc-44f8-a9be-a664f437f780	Product name	2	20200225
3a16d77a-e865-468a-aedf-6e58913c1c21	Product name	3	20190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880	Product name	1	20190320
00d531e4-b130-8c52-eaf9-826cbb6f15dd	Product name	3	20190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659	Product name	9	20190205
22d922aa-c443-d9f3-b23c-03b03a9ad31c	Product name	7	20181220
377068df-225f-7318-a910-a1987cdfa361	Product name	3	20170608
23475c0b-a5b5-4fec-b97f-acca901eae6a	Product name	1	20140718
105ef617-6fa4-6713-326f-72ec8a6b75a9	Product name	1	20140508
332e86c3-7875-ca6e-f934-2206d2b31996	Product name	1	20140508
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
3ed6b849-48b8-8899-c288-6eeb396123b6	Product name	1	20140508
47fd879b-91c5-e1e5-130f-29d082a871ec	Product name	1	20140508
53855190-7124-8179-f018-e792f7c27f28	Product name	1	20140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092	Product name	1	20140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508
96c5169b-5b9d-547d-bf22-d688d91866e4	Product name	1	20140508
b8e0daf1-fb81-290b-c0bf-873be19ef775	Product name	1	20140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00	Product name	1	20140508
c8753a88-edde-8e17-a396-705537b52cee	Product name	1	20140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ce	Product name	1	20140508
cf3a804d-0326-aa22-0142-c184b5657d85	Product name	1	20140508
d83c592c-dd97-4cbf-36ac-13da806684bd	Product name	1	20140508
e01133ad-4dcd-c7f3-454b-2ff569ee160a	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63029-053-24	PercogesicOriginal Strength	1 in 1 BOX	TABLET, COATED	1	2
63029-053-24	PercogesicOriginal Strength	24 in 1 BOTTLE, PLASTIC	TABLET, COATED	24	2
63029-053-50	PercogesicOriginal Strength	1 in 1 BOX	TABLET, COATED	1	2
63029-053-50	PercogesicOriginal Strength	50 in 1 BOTTLE, PLASTIC	TABLET, COATED	50	2
63029-053-90	PercogesicOriginal Strength	1 in 1 BOX	TABLET, COATED	1	2
63029-053-90	PercogesicOriginal Strength	90 in 1 BOTTLE, PLASTIC	TABLET, COATED	90	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63029-053	PERCOGESIC ORIGINAL STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET, COATED [MEDTECH PRODUCTS INC.]	2	Current NDC, 6 package rows	20250116_529974c2-0121-4892-8e47-c2c447581091.zip

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 76 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acetaminophen	ACETAMINOPHEN	Aurohealth LLC	30756257-f748-4a5d-b031-dd267d0f91ad	2023-11-29	Warnings	Exact identifier application number: M013
Aurophen Regular Strength	ACETAMINOPHEN	Aurohealth LLC	8eda893f-5266-4b7a-95b9-2e194973cf06	2023-11-29	Warnings	Exact identifier application number: M013
Childrens Pain Relief	ACETAMINOPHEN	Aurohealth LLC	00ec6518-b5e3-49d1-a342-139381c3bfd2	2023-11-29	Warnings	Exact identifier application number: M013
CHILDRENS PAIN RELIEF	ACETAMINOPHEN	Better Living Brands, LLC	fadb4c09-071f-56c0-e053-6294a90ae6c1	2023-11-28	Warnings	Exact identifier application number: M013
Acetaminophen and Diphenhydramine hydrochloride	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	Better Living Brands, LLC	fc07d516-9ffe-9989-e053-6294a90ae1a5	2023-11-28	Warnings	Exact identifier application number: M013
NOTTS - Tension Headache	ACETAMINOPHEN, CAFFEINE	VIVUNT PHARMA LLC	08f2ae03-967b-ad7e-e063-6294a90a8484	2023-11-24	Warnings	Exact identifier application number: M013
Sanatos Multi Symptoms Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Pharmadel LLC	0a60326a-a17b-e843-e063-6394a90ac211	2023-11-22	Warnings	Exact identifier application number: M013
Sanatos Nighttime Multi Symptoms	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Pharmadel LLC	0ab188f3-f7f9-d665-e063-6294a90a198a	2023-11-22	Warnings	Exact identifier application number: M013
ASPIRIN	ASPIRIN	TIME CAP LABS INC	fe12519c-3e5f-4592-bd34-2d6b81b981f4	2023-11-22	Warnings	Exact identifier application number: M013
Rugby Regular Strength Acetaminophen	ACETAMINOPHEN	A-S Medication Solutions	400d4a29-9e39-4e74-8272-37be5d789924	2023-11-22	Warnings	Exact identifier application number: M013
RIGHT REMEDIES Pain Relief Extra Strength Caplet	ACETAMINOPHEN	Strive Pharmaceuticals Inc.	dcce28d9-8528-489e-b995-1d98e9d0e6ad	2023-11-21	Warnings	Exact identifier application number: M013
Sanatos Multi Symptom Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI	Pharmadel LLC	0ab11691-5b29-55fc-e063-6394a90aa328	2023-11-17	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	A-S Medication Solutions	1e223faa-f6d0-4235-bc4c-6cfca84a5b0a	2023-11-17	Warnings	Exact identifier application number: M013
SanaTos X	ACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN, PHENYLEPHRINE HCI	Pharmadel LLC	85b8ef3d-7318-7f3b-e053-2991aa0a0777	2023-11-14	Warnings	Exact identifier application number: M013
RIGHT REMEDIES EXTRA STRENGTH PM Pain Relief	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE	Strive Pharmaceuticals Inc.	8badbaad-eb35-4251-a779-00474819360d	2023-11-13	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Trifecta Pharmaceuticals USA LLC	09935a74-34b0-0e7c-e063-6294a90a7c83	2023-11-07	Warnings	Exact identifier application number: M013
Pain Relief PM	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	AMERIFOODS TRADING COMPANY	f6dd6396-93e9-1096-e053-6394a90af06d	2023-11-02	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	RETAIL BUSINESS SERVICES , LLC.	eb644e9e-36dc-5f84-e053-2a95a90affa5	2023-11-02	Warnings	Exact identifier application number: M013
Good Sense Childrens Pain and Fever	ACETAMINOPHEN	Proficient Rx LP	46527b1f-7515-44ce-b5cb-9d24223b9af1	2023-11-01	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	A-S Medication Solutions	12feb32b-4b8c-4b17-9e86-cb286457b088	2023-11-01	Warnings	Exact identifier application number: M013

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
TC2D6JAD40	DIPHENHYDRAMINE HYDROCHLORIDE	147-24-0	DIPHENHYDRAMINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1052462	acetaminophen 325 MG / diphenhydrAMINE HCl 12.5 MG Oral Tablet	PSN	529974c2-0121-4892-8e47-c2c447581091	2
1052466	Percogesic Original Strength 325 MG / 12.5 MG Oral Tablet, Reformulated Jan 2011	PSN	529974c2-0121-4892-8e47-c2c447581091	2
1052466	acetaminophen 325 MG / diphenhydramine hydrochloride 12.5 MG Oral Tablet [Percogesic Reformulated Jan 2011]	SBD	529974c2-0121-4892-8e47-c2c447581091	2
1052462	acetaminophen 325 MG / diphenhydramine hydrochloride 12.5 MG Oral Tablet	SCD	529974c2-0121-4892-8e47-c2c447581091	2
1052462	APAP 325 MG / diphenhydramine hydrochloride 12.5 MG Oral Tablet	SY	529974c2-0121-4892-8e47-c2c447581091	2
1052466	APAP 325 MG / Diphenhydramine Hydrochloride 12.5 MG Oral Tablet [Percogesic Reformulated Jan 2011]	SY	529974c2-0121-4892-8e47-c2c447581091	2
1052466	Percogesic Reformulated Jan 2011 (APAP 325 MG / diphenhydramine hydrochloride 12.5 MG) Oral Tablet	SY	529974c2-0121-4892-8e47-c2c447581091	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
63029-053-24	63029005324	1 in 1 BOX				Historical
63029-053-50	63029005350	1 in 1 BOX				Historical
63029-053-90	63029005390	1 BOTTLE, PLASTIC in 1 BOX (63029-053-90) / 90 TABLET, COATED in 1 BOTTLE, PLASTIC	2010-03-19	No	No	Current