FDA.reportPublic FDA data

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 dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…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
IngredientStrength
ACETAMINOPHEN500 mg/1
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
TC2D6JAD40Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1092189Internal RxNorm lookup
1092378Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ed9a9f0-d37e-5c10-e053-2a95a90a559fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73097-013-022023-01-30C16284748780-1f386c649-cd9d-0266-e053-dadaa90a7c1aTylenol PM
73097-013-402023-01-30C16284748780-1f386c649-cd9d-0266-e053-dadaa90a7c1aTylenol PM
73097-013-502023-01-30C16284748780-1f386c649-cd9d-0266-e053-dadaa90a7c1aTylenol PM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73097-013-02Tylenol PM1 in 1 CARTONTABLET, FILM COATED13
73097-013-02Tylenol PM2 in 1 POUCHTABLET, FILM COATED23
73097-013-40Tylenol PM20 in 1 CARTONTABLET, FILM COATED203
73097-013-40Tylenol PM2 in 1 POUCHTABLET, FILM COATED23
73097-013-50Tylenol PM25 in 1 CARTONTABLET, FILM COATED253
73097-013-50Tylenol PM2 in 1 POUCHTABLET, FILM COATED23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73097-013TYLENOL PM (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [SAVINGS DISTRIBUTORS LLC]1Current NDC, Legacy NDC, 6 package rows20190731_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 50 of 79 · 1,561 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Regular Strength Pain ReliefACETAMINOPHENGeri-Care Pharmaceutical Corp6158e954-32d8-4718-e053-2a91aa0a27f32024-12-31WarningsExact identifier
application number: M013
AspirinASPIRINAdvanced Rx Pharmacy of Tennessee, LLCf8375029-e567-c6a5-e053-6394a90a5b672024-12-31WarningsExact identifier
application number: M013
Extra Strength Headache ReliefACETAMINOPHEN, ASPIRIN, AND CAFFEINEDollar General4907056d-6013-46b1-ae86-469dc30015912024-12-31WarningsExact identifier
application number: M013
Pediacare Childrens GrapeACETAMINOPHENRANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTHf9d531a2-234c-4feb-8f05-212dbee83dfe2024-12-30WarningsExact identifier
application number: M013
Pediacare Childrens Acetaminophen GrapeACETAMINOPHENRANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH596372c7-eca3-4527-8e22-ab0751e2526b2024-12-30WarningsExact identifier
application number: M013
Bayer Genuine AspirinBAYER GENUINE ASPIRINLil' Drug Store Products, Inc.d17834d7-cb3e-6bf2-e053-2a95a90ae5c12024-12-30WarningsExact identifier
application number: M013
Extra Strength Pain RelieverACETAMINOPHEN 500 MG, FILM-COATED CAPLETLil' Drug Store Products, Inc.e5fd2b46-683e-4cf5-e053-2995a90a55122024-12-30WarningsExact identifier
application number: M013
Night Time Severe Cold and Cough ReliefACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLChain Drug Consortium, LLCc8e9b57b-83e9-46c5-9791-02c4c2b940042024-12-29WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION INC.1608b4f0-bf20-4024-b8f2-20a4df7a4b212024-12-26WarningsExact identifier
application number: M013
AspirinASPIRINAdvance Pharmaceutical Inc.f6a9ea44-08b8-4a33-bfbd-68cb2d852c392024-12-26WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION INCcfc7eac3-35be-4002-b8ef-be1dfc8caf692024-12-26WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION INCa3031139-4709-43f2-95a8-89840c595f7f2024-12-26WarningsExact identifier
application number: M013
Acetaminophen 250mg Aspirin 250mg Caffeine 65mgACETAMINOPHEN 250MG ASPIRIN 250MG CAFFEINE 65MGWALGREENS CO.98bb28ed-d146-ca3d-e053-2a95a90a9eaf2024-12-26WarningsExact identifier
application number: M013
Acetaminophen 500mg Caffeine 60mg Pyrilamine maleate 15mgACETAMINOPHEN 500MG CAFFEINE 60MG PYRILAMINE MALEATE 15MGWALGREENS CO.982faa74-d498-cd1e-e053-2995a90afa1e2024-12-25WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENAptaPharma Inc.11bf6e1b-aed9-4f8f-9f03-ea911ae9f7022024-12-23WarningsExact identifier
application number: M013
Rugby Regular Strength AcetaminophenACETAMINOPHENRUGBY LABORATORIES295b0d00-4d4a-405f-9325-d01c5d4f3ed42024-12-20WarningsExact identifier
application number: M013
Walgreens Pain Relief PowderASPIRIN AND CAFFEINEWalgreens Co.61493d34-2432-4683-9b32-e1851a4337be2024-12-18WarningsExact identifier
application number: M013
Reese Headache PowdersASPIRIN AND CAFFEINEReese Pharmaceutical Co386f7a6c-4bfc-4140-a67b-07f6b520d58f2024-12-18WarningsExact identifier
application number: M013
NobleAid PAIN RELIEVERASPIRINNoble Otc LLCaa08e488-2f69-4d7e-86ba-ccfad563edcf2024-12-18WarningsExact identifier
application number: M013
Dollar General Headache PowdersASPIRIN AND CAFFEINEDolgencorp, LLC11b0271b-d65c-49c4-a081-d71044a0e04c2024-12-18WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSN8ed9a9f0-d37e-5c10-e053-2a95a90a559f3
1092378Tylenol PM 500 MG / 25 MG Oral TabletPSN8ed9a9f0-d37e-5c10-e053-2a95a90a559f3
1092378acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet [Tylenol PM]SBD8ed9a9f0-d37e-5c10-e053-2a95a90a559f3
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCD8ed9a9f0-d37e-5c10-e053-2a95a90a559f3
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSY8ed9a9f0-d37e-5c10-e053-2a95a90a559f3
1092378APAP 500 MG / Diphenhydramine Hydrochloride 25 MG Oral Tablet [Tylenol PM]SY8ed9a9f0-d37e-5c10-e053-2a95a90a559f3
1092378Tylenol PM (APAP 500 MG / diphenhydramine hydrochloride 25 MG) Oral TabletSY8ed9a9f0-d37e-5c10-e053-2a95a90a559f3
1092378Tylenol PM Extra Strength (APAP 500 MG / diphenhydramine hydrochloride 25 MG) Oral TabletSY8ed9a9f0-d37e-5c10-e053-2a95a90a559f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
73097-013-507309700135025 POUCH in 1 CARTON (73097-013-50) / 2 TABLET, FILM COATED in 1 POUCH25 pouch2019-07-220000-00-00NoNoCurrent