FDA.reportPublic FDA data

Pain Reliever PM

Product NDC
0363-0556
11-digit product format
003630556
Labeler code
0363
Product ID
0363-0556_ba35f08c-d6de-43c5-8c52-201c6a39247d
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Diphenhydramine HCl
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Walgreen Company
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2007-12-17
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0363-05560363-0556-31DDiscontinued by firm2026-10-16
excluded packagepackage0363-05560363-0556-54DDiscontinued by firm2026-10-16
excluded packagepackage0363-05560363-0556-57DDiscontinued by firm2026-10-16

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 · 23 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-050363-0556-57d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-050363-0556-31d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-260363-0556-57f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-260363-0556-31f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-310363-0556-572ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-310363-0556-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-280363-0556-57a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-280363-0556-31a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-210363-0556-57cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-210363-0556-31cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-100363-0556-57cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-100363-0556-31cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-310363-0556-57302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-310363-0556-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-200363-0556-57ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-200363-0556-31ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100363-0556-570efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-100363-0556-310efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-080363-0556-57ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-080363-0556-31ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-030363-0556-57367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-030363-0556-31367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-090363-0556-31557ba5c1ecfa…9c80585c8c6e…

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 Reliever PM
Brand name suffix
Extra Strength
Listing expiration
2026-12-31

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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b4d8860b-d72f-4789-945e-1c6420a8efabAvailable 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0556-01Pain Reliever PMExtra Strength1 in 1 CARTONTABLET, COATED120
0363-0556-01Pain Reliever PMExtra Strength30 in 1 BOTTLE, PLASTICTABLET, COATED3020
0363-0556-09Pain Reliever PMExtra Strength1 in 1 CARTONTABLET, COATED120
0363-0556-09Pain Reliever PMExtra Strength20 in 1 BOTTLE, PLASTICTABLET, COATED2020
0363-0556-31Pain Reliever PMExtra Strength1 in 1 CARTONTABLET, COATED120
0363-0556-31Pain Reliever PMExtra Strength80 in 1 BOTTLE, PLASTICTABLET, COATED8020
0363-0556-54Pain Reliever PMExtra Strength375 in 1 BOTTLE, PLASTICTABLET, COATED37520
0363-0556-57Pain Reliever PMExtra Strength125 in 1 BOTTLE, PLASTICTABLET, COATED12520

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0556-01EA - Each0363-0556b8137f68-38f0-4743-bb43-4468480d5e9d12025-01-14
0363-0556-09EA - Each0363-05561488c3ec-daa4-4620-b9cf-e8a6bea6b59d12013-08-02
0363-0556-54EA - Each0363-0556188ee79f-d073-4965-9b01-2220cf224bdc12015-11-12
0363-0556-57EA - Each0363-05566ca2d00c-a047-4e75-b8a4-090b1510d1e712015-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0556PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [WALGREEN COMPANY]19Current NDC, Legacy NDC, 8 package rows20250101_b4d8860b-d72f-4789-945e-1c6420a8efab.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 7 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
INFANTS PAIN AND FEVERACETAMINOPHENAmazon.com Services LLC112076c4-cac2-45ab-9c77-5573edae71802026-07-10WarningsExact identifier
application number: M013
AspirinASPIRINWal-Mart Stores Inc8ae16aa2-54bc-4c1a-aa36-93524199a67b2026-07-09WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENWildman Business Group943c8f49-e65e-40bc-b364-3274df4d21a22026-07-09WarningsExact identifier
application number: M013
Aspirin Regular StrengthASPIRINFOODHOLD U.S.A., LLC9e09b4fb-e015-45ea-8b1c-27faf65572aa2026-07-09WarningsExact identifier
application number: M013
Tension Headache ReliefACETAMINOPHEN, CAFFEINEWalgreen Companyf13fb7e9-50ea-4e2c-a442-38b1b5b315d72026-07-09WarningsExact identifier
application number: M013
Acetaminophen 500 Pyrilamine Maleate 15 and Caffeine 60ACETAMINOPHEN 500MG PYRILAMINE MALEATE 15MG AND CAFFEINE 60MG TABLETSHealth Pharma USA LLC34eb8a9b-d0ee-13e8-e063-6294a90a2fef2026-07-08WarningsExact identifier
application number: M013
Acetaminophen 250 mg Aspirin 250 mg Caffeine 65 mgACETAMINOPHEN 250 MG ASPIRIN 250 MG CAFFEINE 65 MGHealth Pharma USA LLC3590d417-272b-ae4d-e063-6394a90a5dc62026-07-08WarningsExact identifier
application number: M013
GOODMEDS EXTRA STRENGTH PAIN RELIEF ACETAMINOPHENACETAMINOPHENCabinet Health P.B.C.88884253-5a79-4ac1-b8ce-03966d8b509d2026-07-08WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENHealth Pharma USA LLC671adabe-5f82-4599-a133-3f67ccb340792026-07-07WarningsExact identifier
application number: M013
Pain Reliever PlusACETAMINOPHEN, ASPIRIN, CAFFEINERugby Laboratoriesc3df1652-96a8-6043-e053-2995a90a2d262026-07-07WarningsExact identifier
application number: M013
Rapidol AspirinASPIRINPharmadel LLC00d9ab0d-ff25-784f-e063-6294a90a84972026-07-06WarningsExact identifier
application number: M013
AspirinASPIRINTrifecta Pharmaceuticals USA LLC227cefca-acc4-41d0-e063-6394a90a35b92026-07-06WarningsExact identifier
application number: M013
Extra Strength Pain AidACETAMINOPHEN, ASPIRIN, CAFFEINEHi-Tech Nutaceuticals, LLCa39e4b99-700d-0f5c-e053-2a95a90a6bd32026-07-06WarningsExact identifier
application number: M013
Nighttime Sleep AidACETAMINOPHEN, DIPHENHYDRAMINEHi-Tech Nutraceuticals, LLCa39e2bd6-3d0a-642b-e053-2995a90a42a02026-07-06WarningsExact identifier
application number: M013
Extra Strength AcetaminophenACETAMINOPHENHi-Tech Nutraceuticals, LLCa36be487-7a36-550f-e053-2a95a90a95c12026-07-06WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENHi-Tech Nutraceuticals, LLCa39c524e-c131-d7fb-e053-2995a90a785b2026-07-06WarningsExact identifier
application number: M013
PAIN RELIEVERASPIRIN 81 MGHealth Pharma USA, LLCd60aed37-3a9e-46d1-e053-2995a90a1d1f2026-07-06WarningsExact identifier
application number: M013
Tylenol PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDESelect Consumer Group55d0dceb-c9a9-778e-e063-6294a90a2ad72026-07-04WarningsExact identifier
application number: M013
Bayer Genuine AspirinASPIRINSelect Consumer Group3ca776c2-47ed-5107-e063-6394a90ac5df2026-07-03WarningsExact identifier
application number: M013
AspirinASPIRINRugby Laboratoriesf7ca9f4a-f8ef-46d2-9536-b69541e6653d2026-07-02WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSNb4d8860b-d72f-4789-945e-1c6420a8efab20
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCDb4d8860b-d72f-4789-945e-1c6420a8efab20
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSYb4d8860b-d72f-4789-945e-1c6420a8efab20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0556-01003630556011 BOTTLE, PLASTIC in 1 CARTON (0363-0556-01) / 30 TABLET, COATED in 1 BOTTLE, PLASTIC2007-12-17NoNoCurrent
0363-0556-09003630556091 BOTTLE, PLASTIC in 1 CARTON (0363-0556-09) / 20 TABLET, COATED in 1 BOTTLE, PLASTIC2007-12-170000-00-00NoNoCurrent
0363-0556-31003630556311 BOTTLE, PLASTIC in 1 CARTON (0363-0556-31) > 80 TABLET in 1 BOTTLE, PLASTIC2007-12-172022-02-27NoNoCurrent
0363-0556-5400363055654375 TABLET in 1 BOTTLE, PLASTIC (0363-0556-54) 375 tablet2007-12-170000-00-00NoNoCurrent
0363-0556-5700363055657125 TABLET in 1 BOTTLE, PLASTIC (0363-0556-57) 125 tablet2007-12-170000-00-00NoNoCurrent