Tylenol PM

Product NDC: 73097-013
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 · 60 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	73097-013-40	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	73097-013-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	73097-013-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	73097-013-40	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	73097-013-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	73097-013-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	73097-013-40	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	73097-013-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	73097-013-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	73097-013-40	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	73097-013-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	73097-013-50	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	73097-013-40	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	73097-013-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	73097-013-50	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	73097-013-40	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	73097-013-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	73097-013-50	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	73097-013-40	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	73097-013-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	73097-013-50	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	73097-013-40	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	73097-013-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	73097-013-50	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	73097-013-40	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	73097-013-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	73097-013-50	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	73097-013-40	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	73097-013-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	73097-013-50	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	73097-013-40	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	73097-013-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	73097-013-50	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	73097-013-40	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	73097-013-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	73097-013-50	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	73097-013-40	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	73097-013-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	73097-013-50	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	73097-013-40	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	73097-013-02	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	73097-013-50	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	73097-013-40	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	73097-013-02	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	73097-013-50	`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 34 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Headache Relief	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Walmart Inc.	1557bd9b-3e7c-4769-e063-6394a90a9d91	2025-11-04	Warnings	Exact identifier application number: M013
Adult Low Dose Aspirin	ASPIRIN	Rising Pharma Holdings, Inc.	c3c4854e-726e-4926-b044-a5094943c306	2025-11-04	Warnings	Exact identifier application number: M013
Pain Relief	ACETAMINOPHEN	HYVEE INC	3e50b3f6-1e1a-41b9-e063-6394a90abe36	2025-11-03	Warnings	Exact identifier application number: M013
Good Sense Pain Relief	ACETAMINOPHEN	L. Perrigo Company	447de441-7d28-4415-81c5-4fc05622dd05	2025-11-03	Warnings	Exact identifier application number: M013
Children Acetaminophen Oral Solution	ACETAMINOPHEN	VERITYRX. LLC	42a17f54-7851-84fb-e063-6394a90a9ec1	2025-11-02	Warnings	Exact identifier application number: M013
M-PAP	ACETAMINOPHEN	VERITYRX, LLC	42a1a128-a2dd-bbc9-e063-6294a90a4fe1	2025-11-02	Warnings	Exact identifier application number: M013
Physicians Care Aspirin	ASPIRIN	Acme United Corporation	aa67ea3a-2741-7ee0-e053-2a95a90a6485	2025-10-31	Warnings	Exact identifier application number: M013
PhysiciansCare Non Aspirin Extra Strength	ACETAMINOPHEN	Acme United Corporation	c7006775-bd5b-412f-963d-ce5a158216c5	2025-10-31	Warnings	Exact identifier application number: M013
Pain Reliever	ACETAMINOPHEN	Walgreens	f7aa624b-b00c-4fd3-9965-8e4d2b3eb4ba	2025-10-31	Warnings	Exact identifier application number: M013
Extra Strength Acetaminophen	ACETAMINOPHEN	NuCare Pharmaceuticals, Inc.	41affa1a-5aac-7fc0-e063-6394a90a5557	2025-10-30	Warnings	Exact identifier application number: M013
MAPAP Extra Strength	ACETAMINOPHEN	Major Pharmaceuticals	34a95450-3f04-4de4-9113-73e7bd5724a0	2025-10-29	Warnings	Exact identifier application number: M013
GOODNOW PAIN RELIEF	ACETAMINOPHEN	Gobrands, Inc	4d4a78a5-5a88-4f24-b685-c7c6bb5e989e	2025-10-29	Warnings	Exact identifier application number: M013
Sanaflu Xtra	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	GRANDALL DISTRIBUTING, LLC	4af8a566-5251-4d46-8692-87a3a0748334	2025-10-28	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Rising Pharma Holdings, Inc.	f8237772-7656-49fb-b1de-f8fcb5fa55ee	2025-10-28	Warnings	Exact identifier application number: M013
DG Health Pain Relief	ACETAMINOPHEN	Dolgencorp Inc	42f0c87c-7020-4af7-9f6b-3a774137e564	2025-10-24	Warnings	Exact identifier application number: M013
GOODYS Hangover	ASPIRIN AND CAFFEINE	Medtech Products Inc.	0b0067e0-58b0-4581-aa4b-e398c32c559a	2025-10-23	Warnings	Exact identifier application number: M013
GOODYS Extra Strength Headache Mixed Fruit Blast	ACETAMINOPHEN, ASPIRIN, AND CAFFEINE	Medtech Products Inc.	6cb758bf-5a50-46bb-96e7-65b810b12de0	2025-10-23	Warnings	Exact identifier application number: M013
Nyt Time Sleep Caps	DIPHENHYDRAMINE HYDROCHLORIDE	DISCOUNT DRUG MART	e3f4d063-921d-4503-89a6-26cc9c46b4c9	2025-10-23	Warnings	Exact identifier application number: M013
Anacin	ASPRIN AND CAFFEINE	Insight Pharmaceuticals LLC	51ab0ee3-3c94-424d-a30a-2d6c14e3d8ff	2025-10-23	Warnings	Exact identifier application number: M013
Goodys Back and Body Pain	ACETAMINOPHEN AND ASPRIN	Medtech Products Inc.	055d0288-61d4-48bc-b91f-6ecc1969beb8	2025-10-23	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
73097-013-02	73097001302	1 POUCH in 1 CARTON (73097-013-02) / 2 TABLET, FILM COATED in 1 POUCH	1 pouch	2019-07-22	0000-00-00	No	No	Current
73097-013-40	73097001340	20 POUCH in 1 CARTON (73097-013-40) / 2 TABLET, FILM COATED in 1 POUCH	20 pouch	2019-07-22	0000-00-00	No	No	Current
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