Tylenol PM

Product NDC: 73097-013
Requested package NDC: 73097-013-50
11-digit product format: 730970013
Labeler code: 73097
Product ID: 73097-013_518f65e6-62bf-d778-e063-6394a90a67de
Type: HUMAN OTC DRUG
Nonproprietary name: ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Savings Distributors LLC
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-07-22
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: 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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`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: Tylenol PM
Listing expiration: 2027-12-31

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
8ed9a9f0-d37e-5c10-e053-2a95a90a559f	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
73097-013-02	2023-01-30	C162847	48780-1	f386c649-cd9d-0266-e053-dadaa90a7c1a	Tylenol PM
73097-013-40	2023-01-30	C162847	48780-1	f386c649-cd9d-0266-e053-dadaa90a7c1a	Tylenol PM
73097-013-50	2023-01-30	C162847	48780-1	f386c649-cd9d-0266-e053-dadaa90a7c1a	Tylenol PM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
73097-013-02	Tylenol PM	1 in 1 CARTON	TABLET, FILM COATED	1	3
73097-013-02	Tylenol PM	2 in 1 POUCH	TABLET, FILM COATED	2	3
73097-013-40	Tylenol PM	20 in 1 CARTON	TABLET, FILM COATED	20	3
73097-013-40	Tylenol PM	2 in 1 POUCH	TABLET, FILM COATED	2	3
73097-013-50	Tylenol PM	25 in 1 CARTON	TABLET, FILM COATED	25	3
73097-013-50	Tylenol PM	2 in 1 POUCH	TABLET, FILM COATED	2	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
73097-013	TYLENOL PM (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [SAVINGS DISTRIBUTORS LLC]	1	Current NDC, Legacy NDC, 6 package rows	20190731_8ed9a9f0-d37e-5c10-e053-2a95a90a559f.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 46 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Acetaminophen	ACETAMINOPHEN	Bryant Ranch Prepack	bdc466c9-d9ae-4293-b7ea-46fb517661c6	2025-04-01	Warnings	Exact identifier application number: M013
Adult Low Dose Enteric Coated Aspirin	ASPIRIN	Geri-Care Pharmaceutical Corp	e327a52a-0e31-44b7-9823-7f60d070ae52	2025-04-01	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Proficient Rx LP	9af5ccc8-aac0-4339-a9f6-58fdc9b91c57	2025-04-01	Warnings	Exact identifier application number: M013
ASPIRIN 325 MG EC	ASPIRIN	Bryant Ranch Prepack	9d0449d2-c0c6-4e74-931b-35dc62584028	2025-03-31	Warnings	Exact identifier application number: M013
Aspirin 81 mg	ASPIRIN	Bryant Ranch Prepack	cce1e8bd-63c8-403a-bc32-e6788493f604	2025-03-31	Warnings	Exact identifier application number: M013
Adwe Feverx Acetaminophen Caplets, 500 mg Extra Strength	ACETAMINOPHEN	Aurex Laboratories Limited Liability Company	948c5826-6f35-484d-bb3f-cecf6a4b5c13	2025-03-31	Warnings	Exact identifier application number: M013
Infants Pain and Fever	ACETAMINOPHEN	WALGREENS	281a530b-c759-50eb-e063-6394a90abb4f	2025-03-28	Warnings	Exact identifier application number: M013
Pain Reliever PM	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	WR Group, Inc.	8281771c-485c-42a9-9a1c-9a7a4298c5b8	2025-03-28	Warnings	Exact identifier application number: M013
Acetaminophen Regular strength	ACETAMINOPHEN	PD-Rx Pharmaceuticals, Inc.	4181efc2-d183-410c-b647-233444c57e32	2025-03-20	Warnings	Exact identifier application number: M013
CounterAct Pain	ACETAMINOPHEN	Melaleuca, Inc.	7faf76b4-7f25-377d-e053-2a91aa0a19d4	2025-03-20	Boxed warning, Warnings	Exact identifier application number: M013
Mejoral	ACETAMINOPHEN, CAFFEINE	OPMX LLC	0bccf571-fcb9-2dd5-e063-6294a90a5f16	2025-03-19	Warnings	Exact identifier application number: M013
ARTRIFIN 24 CAPLETS	ACETAMINOPHEN, ASPIRIN, CAFFEINE	OPMX LLC	e7f15c2b-a730-b54f-e053-2a95a90a3b3e	2025-03-19	Warnings	Exact identifier application number: M013
Pain Reliever PM	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	TARGET Corporation	1fc3806e-a5c4-4a6e-951b-dfbf9f5771f1	2025-03-17	Warnings	Exact identifier application number: M013
Signature Select Effervescent Pain Relief	ASPIRIN	Safeway Inc.	304fca65-2867-c963-e063-6394a90a183f	2025-03-14	Warnings	Exact identifier application number: M013
GOOD REMEDIES Extra Strength Pain Relief PM Caplet	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE	Strive Pharmaceuticals Inc.	2d642d8e-c154-a970-e063-6294a90a03bf	2025-03-14	Warnings	Exact identifier application number: M013
Pain Relief	ACETAMINOPHEN	DISCOUNT DRUG MART	97f78c4a-9d0d-4fe1-8b2b-d5f8ab939ac4	2025-03-07	Warnings	Exact identifier application number: M013
Redicare Non-Aspirin 500mg	REDICARE NON-ASPIRIN, ACETAMINOPHEN 500MG	Redicare LLC	2f229898-1777-732c-e063-6394a90a76bc	2025-03-04	Warnings, Adverse reactions	Exact identifier application number: M013
Major Extra Strength Acetaminophen Liquid	ACETAMINOPHEN	Major Pharmaceuticals	2f3af4dd-45d5-87b4-e063-6294a90ab3cc	2025-02-28	Warnings	Exact identifier application number: M013
LOW DOSE ASPIRIN	ASPIRIN	NCS HealthCare of KY, LLC dba Vangard Labs	ed9a71d6-a56e-416a-bb89-6d41307efc5a	2025-02-27	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	PD-Rx Pharmaceuticals, Inc.	77429b7f-78e4-42c0-8679-ae8da1748848	2025-02-26	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	8ed9a9f0-d37e-5c10-e053-2a95a90a559f	3
1092378	Tylenol PM 500 MG / 25 MG Oral Tablet	PSN	8ed9a9f0-d37e-5c10-e053-2a95a90a559f	3
1092378	acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet [Tylenol PM]	SBD	8ed9a9f0-d37e-5c10-e053-2a95a90a559f	3
1092189	acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	8ed9a9f0-d37e-5c10-e053-2a95a90a559f	3
1092189	APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet	SY	8ed9a9f0-d37e-5c10-e053-2a95a90a559f	3
1092378	APAP 500 MG / Diphenhydramine Hydrochloride 25 MG Oral Tablet [Tylenol PM]	SY	8ed9a9f0-d37e-5c10-e053-2a95a90a559f	3
1092378	Tylenol PM (APAP 500 MG / diphenhydramine hydrochloride 25 MG) Oral Tablet	SY	8ed9a9f0-d37e-5c10-e053-2a95a90a559f	3
1092378	Tylenol PM Extra Strength (APAP 500 MG / diphenhydramine hydrochloride 25 MG) Oral Tablet	SY	8ed9a9f0-d37e-5c10-e053-2a95a90a559f	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
73097-013-50	73097001350	25 POUCH in 1 CARTON (73097-013-50) / 2 TABLET, FILM COATED in 1 POUCH	25 pouch	2019-07-22	0000-00-00	No	No	Current