Pain Relief PM

Product NDC: 63868-325
11-digit product format: 638680325
Labeler code: 63868
Product ID: 63868-325_2435717d-bbb9-9e00-e063-6394a90a75ad
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen and Diphenhydramine Hydrochloride
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Chain Drug Marketing Association
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2007-11-08
Marketing end: 2026-11-30
Substance: ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 500; 25 mg/1; mg/1
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag: No
Current FDA listing: Yes

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: Pain Relief PM
Brand name suffix: Extra Strength

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	500 mg/1
DIPHENHYDRAMINE HYDROCHLORIDE	25 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1092189	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
475becec-1a56-4cfa-a0c5-562f8772adfb	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
63868-325-01	Pain Relief PMExtra Strength	100 in 1 BOTTLE, PLASTIC	TABLET, COATED	100	6
63868-325-50	Pain Relief PMExtra Strength	50 in 1 BOTTLE, PLASTIC	TABLET, COATED	50	6
63868-325-50	Pain Relief PMExtra Strength	1 in 1 CARTON	TABLET, COATED	1	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63868-325-01	EA - Each	63868-325	edd381ef-6b41-4bda-9c5b-ac61944f1e39	1	2014-11-05
63868-325-50	EA - Each	63868-325	cc262c38-7bbe-486e-a4f3-11d3895a46bf	1	2014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]	1
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]	1
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]	1
COPOVIDONE K25-31	INACTIVE INGREDIENT	D9C330MD8B	PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]	1
SODIUM STARCH GLYCOLATE TYPE A CORN	INACTIVE INGREDIENT	AG9B65PV6B	PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63868-325	PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]	6	Current NDC, Legacy NDC, 3 package rows	20241013_475becec-1a56-4cfa-a0c5-562f8772adfb.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 60 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acetaminophen Regular Strength	ACETAMINOPHEN	United Natural Foods, Inc. dba UNFI	1462b308-a6a5-49ca-ab29-cacbf62caf0b	2024-10-17	Warnings	Exact identifier application number: M013
Acetaminophen Extra Strength	ACETAMINOPHEN	United Natural Foods, Inc. dba UNFI	f3db8598-fe0e-4c53-a023-5f5f8f002cc6	2024-10-17	Warnings	Exact identifier application number: M013
acetaminophen pm extra strength	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	United Natural Foods, Inc. dba UNFI	f86a11af-6d3c-4638-870d-a663ddf49371	2024-10-17	Warnings	Exact identifier application number: M013
Acetaminophen Gelcaps Extra Strength	ACETAMINOPHEN	United Natural Foods, Inc. dba UNFI	3588a3ef-a493-43ed-96e0-c259f0d087db	2024-10-17	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	STRATEGIC SOURCING SERVICES LLC	a2186895-944b-48cb-b3c2-eac208866c34	2024-10-17	Warnings	Exact identifier application number: M013
Pain Relief Regular Strength	ACETAMINOPHEN	STRATEGIC SOURCING SERVICES LLC	6a5d43c8-f4b7-4447-b2e1-53eb12208ef0	2024-10-17	Warnings	Exact identifier application number: M013
Enteric Coated Aspirin	ASPIRIN	STRATEGIC SOURCING SERVICES LLC	32cc6e05-84c1-4710-bebc-cb6e7133dc54	2024-10-17	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	STRATEGIC SOURCING SERVICES LLC	2ca87a29-1f54-4da4-a66f-3b3dd4f0396c	2024-10-17	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	STRATEGIC SOURCING SERVICES LLC	9f0aef5d-20b0-469d-a58d-1cbf83a0dd8e	2024-10-17	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Kroger Company	453f62d5-f580-4d19-bfae-4f78c2a6b6d6	2024-10-16	Warnings	Exact identifier application number: M013
Acetaminophen Extra Strength	ACETAMINOPHEN	FSA Store Inc.	ec6add55-f4a3-7818-e053-2a95a90aee04	2024-10-16	Warnings	Exact identifier application number: M013
ASPIRIN	ASPIRIN	FSA Store Inc.	062e7b7b-d052-82b0-e063-6294a90a7cce	2024-10-16	Warnings	Exact identifier application number: M013
Acetaminophen PM	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	FSA STORE INC.	f4322f34-ac19-371e-e053-2a95a90ac864	2024-10-16	Warnings	Exact identifier application number: M013
Low dose Chewable Aspirin	ASPIRIN	FSA STORE INC.	f939b44c-93b6-ca61-e053-6394a90ae586	2024-10-16	Warnings	Exact identifier application number: M013
Pain Relief	ACETAMINOPHEN	DISCOUNT DRUG MART	850b5ad8-8774-413c-ae38-022215a94f95	2024-10-16	Warnings	Exact identifier application number: M013
LOW DOSE ASPIRIN	ASPIRIN	DISCOUNT DRUG MART	af0f50d2-3e2d-f723-e053-2995a90a0d4b	2024-10-16	Warnings	Exact identifier application number: M013
Enteric Coated Aspirin	ASPIRIN	DISCOUNT DRUG MART	03ed19dd-1cfc-47d5-b83e-ffa2ebe93f48	2024-10-16	Warnings	Exact identifier application number: M013
PAIN RELIEF Regular Strength	ACETAMINOPHEN	AMERICAN SALES COMPANY	2e3eabc8-193b-4397-a43c-db838eb16e67	2024-10-15	Warnings	Exact identifier application number: M013
Chewable Aspirin	ASPIRIN	RETAIL BUSINESS SERVICES , LLC.	c94d68ea-7f25-881f-e053-2995a90aa47f	2024-10-15	Warnings	Exact identifier application number: M013
LOW DOSE ASPIRIN	ASPIRIN	RETAIL BUSINESS SERVICES , LLC.	c94d750e-5a85-77f5-e053-2995a90a6915	2024-10-15	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
1092189	acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral Tablet	PSN	475becec-1a56-4cfa-a0c5-562f8772adfb	6
1092189	acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	475becec-1a56-4cfa-a0c5-562f8772adfb	6
1092189	APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet	SY	475becec-1a56-4cfa-a0c5-562f8772adfb	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63868-325-01	63868032501	100 TABLET, COATED in 1 BOTTLE, PLASTIC (63868-325-01)	2007-11-08	2026-11-30	No	No	Current
63868-325-50	63868032550	1 BOTTLE, PLASTIC in 1 CARTON (63868-325-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC	2007-11-08	2026-11-30	No	No	Current