Home NDC 69168-393-02 Pain Relief PM
Product NDC 69168-393
Requested package NDC 69168-393-02
11-digit product format 691680393
Labeler code 69168
Product ID 69168-393_d525d4d3-adac-40fb-a927-832f7d6a831b
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen 500 mg and Diphenhydramine HCl 25 mg
Dosage form TABLET
Route ORAL
Labeler Allegiant Health
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-12-23
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 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 Relief PM
Brand name suffix Extra Strength
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 500 mg/1 DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup TC2D6JAD40 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1092189 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69168-393-02 Pain Relief PMExtra Strength 150 in 1 BOTTLE TABLET 150 6 69168-393-24 Pain Relief PMExtra Strength 1 in 1 CARTON TABLET 1 6 69168-393-24 Pain Relief PMExtra Strength 24 in 1 BOTTLE TABLET 24 6 69168-393-26 Pain Relief PMExtra Strength 1 in 1 CARTON TABLET 1 6 69168-393-26 Pain Relief PMExtra Strength 20 in 1 BOTTLE TABLET 20 6 69168-393-50 Pain Relief PMExtra Strength 50 in 1 BOTTLE TABLET 50 6 69168-393-50 Pain Relief PMExtra Strength 1 in 1 CARTON TABLET 1 6 69168-393-99 Pain Relief PMExtra Strength 365 in 1 BOTTLE TABLET 365 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69168-393 PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN 500 MG AND DIPHENHYDRAMINE HCL 25 MG) TABLET [ALLEGIANT HEALTH] 6 Current NDC, Legacy NDC, 8 package rows 20231114_423a8445-964c-4cdb-889a-f391ca5253e7.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 83 · 1,657 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69168-393-02 69168039302 150 TABLET in 1 BOTTLE (69168-393-02) 150 tablet 2014-12-23 0000-00-00 No No Current