FDA.reportPublic FDA data

Pain Relief PM

Product NDC
21130-095
11-digit product format
211300095
Labeler code
21130
Product ID
21130-095_39f81b58-dec5-deb5-e063-6394a90ad1f0
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen and Diphenhydramine Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Safeway
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-12-23
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

Additional Listing Data#

Finished product
Yes
Brand name base
Pain Relief PM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/1
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, TC2D6JAD40
Rxcui1092189

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
21130-095-01Pain Relief PM24 in 1 BOTTLE, PLASTICTABLET, COATED245
21130-095-01Pain Relief PM1 in 1 CARTONTABLET, COATED15
21130-095-03Pain Relief PM1 in 1 CARTONTABLET, COATED15
21130-095-03Pain Relief PM100 in 1 BOTTLE, PLASTICTABLET, COATED1005
21130-095-14Pain Relief PM200 in 1 BOTTLE, PLASTICTABLET, COATED2005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-095PAIN RELIEF PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SAFEWAY]4Current NDC, Legacy NDC, 5 package rows20241030_f9597abc-3f01-4b94-8078-228e0b74677e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSNf9597abc-3f01-4b94-8078-228e0b74677e5
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCDf9597abc-3f01-4b94-8078-228e0b74677e5
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSYf9597abc-3f01-4b94-8078-228e0b74677e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
21130-095-01211300095011 BOTTLE, PLASTIC in 1 CARTON (21130-095-01) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC2015-12-230000-00-00NoNoCurrent
21130-095-03211300095031 BOTTLE, PLASTIC in 1 CARTON (21130-095-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC2015-12-230000-00-00NoNoCurrent
21130-095-1421130009514200 TABLET, COATED in 1 BOTTLE, PLASTIC (21130-095-14) 2015-12-230000-00-00NoNoCurrent