FDA.reportPublic FDA data

Pain Relief Acetaminophen PM

Product NDC
11822-0556
11-digit product format
118220556
Labeler code
11822
Product ID
11822-0556_d7058f45-483c-4b4d-a1ce-41c52c43a654
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen and Diphenhydramine HCl
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Rite Aid Corporation
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
2027-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage11822-055611822-0556-3DDiscontinued by firm2026-08-17
excluded packagepackage11822-055611822-0556-9DDiscontinued by firm2026-08-17

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 · 24 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 2025-12-0511822-0556-9d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0511822-0556-3d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2611822-0556-9f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2611822-0556-3f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3111822-0556-92ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3111822-0556-32ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2811822-0556-9a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2811822-0556-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2111822-0556-9cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2111822-0556-3cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1011822-0556-9cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1011822-0556-3cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3111822-0556-9302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3111822-0556-3302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2011822-0556-9ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2011822-0556-3ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1011822-0556-90efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1011822-0556-30efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0811822-0556-9ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0811822-0556-3ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0311822-0556-9367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0311822-0556-3367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0911822-0556-9557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0911822-0556-3557ba5c1ecfa…9c80585c8c6e…

Additional Listing Data#

Finished product
Yes
Brand name base
Pain Relief Acetaminophen 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 · 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
f77f0120-4042-4b11-ba9c-cd35e1cd0beeAvailable 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
11822-0556-1Pain Relief Acetaminophen PM80 in 1 BOTTLE, PLASTICTABLET, COATED8020
11822-0556-3Pain Relief Acetaminophen PM80 in 1 BOTTLE, PLASTICTABLET, COATED8020
11822-0556-3Pain Relief Acetaminophen PM1 in 1 CARTONTABLET, COATED120
11822-0556-9Pain Relief Acetaminophen PM20 in 1 BOTTLE, PLASTICTABLET, COATED2020
11822-0556-9Pain Relief Acetaminophen PM1 in 1 CARTONTABLET, COATED120

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [RITE AID]6
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40ACETAMINOPHEN PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [RITE AID]6
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [RITE AID]6
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MACETAMINOPHEN PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [RITE AID]6
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ACETAMINOPHEN PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [RITE AID]6
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDACETAMINOPHEN PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [RITE AID]6
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYACETAMINOPHEN PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [RITE AID]6
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PACETAMINOPHEN PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [RITE AID]6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOACETAMINOPHEN PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [RITE AID]6
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AACETAMINOPHEN PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [RITE AID]6
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ACETAMINOPHEN PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [RITE AID]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ACETAMINOPHEN PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [RITE AID]6
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APACETAMINOPHEN PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [RITE AID]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPACETAMINOPHEN PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [RITE AID]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0556PAIN RELIEF ACETAMINOPHEN PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET, COATED [RITE AID CORPORATION]19Current NDC, Legacy NDC, 5 package rows20250105_f77f0120-4042-4b11-ba9c-cd35e1cd0bee.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 1 of 85 · 1,692 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetaminophenACETAMINOPHENWalgreens543f93d1-df14-0bd2-e063-6294a90a44132026-08-24WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENAkron Pharma Inc.ab79fd60-8315-4c63-8045-1b0511ac268f2026-08-24WarningsExact identifier
application number: M013
Genexa Infants Pain and FeverACETAMINOPHENGenexa Inc.4fd048c3-70bc-2ea7-e063-6394a90a55f22026-08-22WarningsExact identifier
application number: M013
Genexa Kids Pain and FeverACETAMINOPHENGenexa Inc.59adabeb-97e8-2de4-e063-6394a90acc472026-08-22WarningsExact identifier
application number: M013
Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEPublix Super Markets Inca876daa7-ade3-497d-87bb-46d6e4dc185a2026-08-21WarningsExact identifier
application number: M013
equate aspirinASPIRINWal-Mart Stores Incea3f8eed-7b70-4156-9586-125d27bf29a82026-08-19WarningsExact identifier
application number: M013
CARDIASPIRIN PROTECTASPIRINOPMX LLC03774690-662b-1c30-e063-6294a90a34882026-08-19WarningsExact identifier
application number: M013
aspirin chewable, low doseASPIRINUnited Natural Foods, Inc. dba UNFI6a6ac7fe-91a4-4b55-979a-b53b51505d8b2026-08-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENSam's West Inc1098d0e7-8202-4018-a2d2-b0c80ee58b562026-08-19WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINESafeway, Inc.5e77dca4-2ff8-4a8c-94bd-f224b680ca232026-08-19WarningsExact identifier
application number: M013
dg health pain relief pm extra strengthACETAMINOPHEN, DIPHENHYDRAMINE HCLDolgencorp Inc4d1eddf0-eff7-4c47-b312-30dee08d9e5f2026-08-19WarningsExact identifier
application number: M013
Headache Formula Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEARMY AND AIR FORCE EXCHANGE SERVICEee8d0961-7572-471f-8c96-b4c0bd354de22026-08-18WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENRugby Laboratories76f10ee2-1d6a-097c-e053-2991aa0af5262026-08-18WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENMajor Pharmaceuticals780aad35-d0f1-44b1-e053-2991aa0af9a72026-08-18WarningsExact identifier
application number: M013
CHILDRENS PAIN AND FEVERACETAMINOPHENAmazon.com Services LLC5eacbc4f-d20a-4c22-9680-4a648e24de432026-08-18WarningsExact identifier
application number: M013
Pain Relief ChildrensACETAMINOPHENWinCo Foods, LLC15921c3f-e8d4-4794-983f-63bb926f6f862026-08-15WarningsExact identifier
application number: M013
Childrens Pain plus Fever ReliefACETAMINOPHENCVS PHARMACYe4cbfb06-d826-4d08-95d6-60305c4176252026-08-14WarningsExact identifier
application number: M013
Childrens Pain ReliefACETAMINOPHENCVS Pharmacy,Inc.3738d35c-1e83-40df-9292-c54e6b2c83532026-08-14WarningsExact identifier
application number: M013
CVS Childrens Pain plus Fever ReliefACETAMINOPHENCVS PHARMACY22a48a33-995b-481e-9e4e-1ad7ec346f442026-08-14WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN AND CAFFEINECVS Pharmacy31ccc867-ca83-70a9-f3d5-5644030047b82026-08-13WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSNf77f0120-4042-4b11-ba9c-cd35e1cd0bee20
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCDf77f0120-4042-4b11-ba9c-cd35e1cd0bee20
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSYf77f0120-4042-4b11-ba9c-cd35e1cd0bee20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
11822-0556-11182205560180 TABLET, COATED in 1 BOTTLE, PLASTIC (11822-0556-1) 2007-12-170000-00-00NoNoCurrent
11822-0556-31182205560380 in 1 BOTTLE, PLASTICHistorical
11822-0556-91182205560920 in 1 BOTTLE, PLASTICHistorical