FDA.reportPublic FDA data

Pain Relief PM

Product NDC
76168-119
11-digit product format
761680119
Labeler code
76168
Product ID
76168-119_6c30260f-b9e7-58c3-e053-2991aa0a818c
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen PM
Dosage form
TABLET
Route
ORAL
Labeler
Velocity Pharma
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-12-05
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 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
c1c1de91-6a54-4d91-93a9-b6be6d7c7dfbAvailable 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
76168-119-25Pain Relief PM50 in 1 BOTTLETABLET502
76168-119-25Pain Relief PM1 in 1 CARTONTABLET12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76168-119PAIN RELIEF PM (ACETAMINOPHEN PM) TABLET [VELOCITY PHARMA]2Current NDC, Legacy NDC, 2 package rows20180515_c1c1de91-6a54-4d91-93a9-b6be6d7c7dfb.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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain Relief PMACETAMINOPHEN PMVelocity Pharmac1c1de91-6a54-4d91-93a9-b6be6d7c7dfb2018-05-14WarningsExact identifier
ndc (product): 76168-119

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSNc1c1de91-6a54-4d91-93a9-b6be6d7c7dfb2
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCDc1c1de91-6a54-4d91-93a9-b6be6d7c7dfb2
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSYc1c1de91-6a54-4d91-93a9-b6be6d7c7dfb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76168-119-257616801192550 CARTON in 1 BOTTLE (76168-119-25) / 1 TABLET in 1 CARTON50 carton2018-05-140000-00-00NoNoCurrent