TYLENOL PM EXTRA STRENGTH

Product NDC: 70264-028
11-digit product format: 702640028
Labeler code: 70264
Product ID: 70264-028_43c8c37c-62db-f6e0-e063-6394a90aab46
Type: HUMAN OTC DRUG
Nonproprietary name: ACETAMINOPHEN
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: R J General Corporation
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2021-05-01
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
Listing certified through: 2026-12-31
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: TYLENOL PM EXTRA STRENGTH
Listing expiration: 2026-12-31

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1092189	Internal RxNorm lookup
1092378	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
a40ea0e3-d666-4605-b5e0-beeaf8f586f2	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70264-028-01	TYLENOL PM EXTRA STRENGTH	2 in 1 POUCH	TABLET, FILM COATED	2		4
70264-028-01	TYLENOL PM EXTRA STRENGTH	50 in 1 BOX	TABLET, FILM COATED	50		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70264-028	TYLENOL PM EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [R J GENERAL CORPORATION]	3	Current NDC, Legacy NDC, 2 package rows	20241030_a40ea0e3-d666-4605-b5e0-beeaf8f586f2.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 75 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lil Drug Store Aspirin 325	ASPIRIN	Lil Drug Store Products, Inc	de59aae2-f794-4243-acc8-37a10e27abde	2023-12-15	Warnings	Exact identifier application number: M013
Pain Reliever	ACETAMINOPHEN TABLET, EXTRA STRENGTH	Lil' Drug Store Products, Inc.	f0fdab5a-9d07-57aa-e053-2a95a90adc7f	2023-12-15	Warnings	Exact identifier application number: M013
BC Cherry	ASPIRIN AND CAFFEINE	Lil' Drug Store Products, Inc	79ea721b-d656-44f7-9d13-390debee7be0	2023-12-15	Warnings	Exact identifier application number: M013
Alka-Seltzer	BUFFERED ASPIRIN	Lil' Drug Store Products, Inc.	0c7a60e7-0bde-9aa2-e063-6294a90a3209	2023-12-14	Warnings	Exact identifier application number: M013
Circle K Aspirin 325	ASPIRIN	Lil Drug Store Products, Inc	4cd306e3-2119-4272-9da4-a848fe2746fa	2023-12-14	Warnings	Exact identifier application number: M013
Circle K Pain Reliever Extra Strength	ACETAMINOPHEN	Lil' Drug Store Products, Inc.	f2359bc3-901f-4ecb-b402-cb2fe404a935	2023-12-14	Warnings	Exact identifier application number: M013
Childrens Pain Relief	ACETAMINOPHEN	DISCOUNT DRUG MART	c55b8f9d-1396-43c0-acc9-5e3485eadb07	2023-12-08	Warnings	Exact identifier application number: M013
Childrens Pain Relief	ACETAMINOPHEN	DISCOUNT DRUG MART	775519ad-5683-451f-9bfc-5fafc70c68ec	2023-12-08	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	WALGREEN CO.	c20c814b-35f5-4c46-e053-2a95a90a50f2	2023-12-08	Warnings	Exact identifier application number: M013
Acetaminophen Extra Strength	ACETAMINOPHEN	Better Living Brands LLC	f9859be4-6d0b-2ab8-e053-6294a90aa862	2023-12-06	Warnings	Exact identifier application number: M013
Aurophen Regular Strength	ACETAMINOPHEN	KROGER COMPANY	b9b7b849-c3b3-9af7-e053-2a95a90a0077	2023-12-06	Warnings	Exact identifier application number: M013
Acetaminophen Regular Strength	ACETAMINOPHEN	KROGER COMPANY	cf649478-57d2-cc88-e053-2a95a90ad1ba	2023-12-06	Warnings	Exact identifier application number: M013
Acetaminophen Extra Strength	ACETAMINOPHEN	KROGER COMPANY	b9b6f878-1ec8-3dc0-e053-2995a90a5414	2023-12-06	Warnings	Exact identifier application number: M013
Pain Reliever	ACETAMINOPHEN	WALGREEN CO.	a48c522c-76c5-49f8-8c4d-3ee6b221e6f3	2023-12-06	Warnings	Exact identifier application number: M013
Pain Reliever	ACETAMINOPHEN	WALGREEN CO.	cc939a7c-ce56-5dd6-e053-2995a90aa8af	2023-12-06	Warnings	Exact identifier application number: M013
Alka-Seltzer Original Flavor	BUFFERED ASPIRIN, EFFERVESCENT TABLET	Lil' Drug Store Products, Inc.	ea5df8be-a08c-5fa3-e053-2995a90a0bac	2023-12-06	Warnings	Exact identifier application number: M013
Ringl	ACETAMINOPHEN	Sato Pharmaceutical Co., Ltd.	ba5a0286-3e0f-4bef-96e5-29d92f51f432	2023-12-06	Warnings	Exact identifier application number: M013
Pain Relief Childrens	ACETAMINOPHEN	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	41633554-474e-4d3c-9187-d90487d2ae8c	2023-12-06	Warnings	Exact identifier application number: M013
Acetaminophen Extra Strength	ACETAMINOPHEN	Family Dollar Stores, LLC	f86dcbb8-debc-4bce-e053-6294a90a7a02	2023-12-05	Warnings	Exact identifier application number: M013
Sanatos Multi Symptom Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	Pharmadel LLC	0a5fc0ef-ba34-bb0b-e063-6394a90af7d9	2023-12-01	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
1092189	acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral Tablet	PSN	a40ea0e3-d666-4605-b5e0-beeaf8f586f2	4
1092378	Tylenol PM 500 MG / 25 MG Oral Tablet	PSN	a40ea0e3-d666-4605-b5e0-beeaf8f586f2	4
1092378	acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet [Tylenol PM]	SBD	a40ea0e3-d666-4605-b5e0-beeaf8f586f2	4
1092189	acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	a40ea0e3-d666-4605-b5e0-beeaf8f586f2	4
1092189	APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet	SY	a40ea0e3-d666-4605-b5e0-beeaf8f586f2	4
1092378	APAP 500 MG / Diphenhydramine Hydrochloride 25 MG Oral Tablet [Tylenol PM]	SY	a40ea0e3-d666-4605-b5e0-beeaf8f586f2	4
1092378	Tylenol PM (APAP 500 MG / diphenhydramine hydrochloride 25 MG) Oral Tablet	SY	a40ea0e3-d666-4605-b5e0-beeaf8f586f2	4
1092378	Tylenol PM Extra Strength (APAP 500 MG / diphenhydramine hydrochloride 25 MG) Oral Tablet	SY	a40ea0e3-d666-4605-b5e0-beeaf8f586f2	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70264-028-01	70264002801	50 POUCH in 1 BOX (70264-028-01) / 2 TABLET, FILM COATED in 1 POUCH	50 pouch	2021-05-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TYLENOL ® PM EXTRA STRENGTH	R J General Corporation \| Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	2025-11-17	HUMAN OTC DRUG LABEL	4