NDC 69607-8630-01 - Pain Reliever PM

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
69607-8630
Requested NDC
69607-8630-01
Package NDCs from labels
69607-8630-1, 69607-8630-01
Manufacturer
WR Group, Inc.
Effective date
2025-03-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Drug FactsWR Group, Inc.2025-03-28HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69607-8630-1Pain Reliever PM24 in 1 BOTTLE, PLASTICTABLET, COATED242
69607-8630-1Pain Reliever PM1 in 1 BOXTABLET, COATED12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69607-8630PAIN RELIEVER PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [WR GROUP, INC.]2Current NDC, 2 package rows20250331_8281771c-485c-42a9-9a1c-9a7a4298c5b8.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 52 of 352 · 7,030 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCardinal Health 110, LLC. dba Leader333c7042-95b8-4d98-9df1-4287017afa362026-04-25WarningsExact identifier
unii: 362O9ITL9D
Geri-Dryl allergy reliefDIPHENHYDRAMINE HCLSportpharm LLC2c4e0d5e-958d-4274-876a-52126c795c0f2026-04-24WarningsExact identifier
unii: TC2D6JAD40
Medique at Home AspirinASPIRINSportpharm LLC0f2aa75e-534f-478b-811e-fb492b7af9bb2026-04-24WarningsExact identifier
application number: M013
Medique at Home APAP Extra StrengthACETAMINOPHEN 500 MGSportpharm LLCcc280926-ad94-4017-a04a-b4315807eacb2026-04-24WarningsExact identifier
application number: M013
unii: 362O9ITL9D
ALKA SELTZER COLD Cold Flu Severe Fast DissolveCHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEBayer HealthCare LLC.5036dc50-e95b-ea8d-e063-6394a90a6cfe2026-04-24WarningsExact identifier
unii: 362O9ITL9D
AspirinASPIRINHealth Pharma USA LLC503868bb-48e0-b718-e063-6394a90a9c5b2026-04-24WarningsExact identifier
application number: M013
BC CHERRYASPIRIN AND CAFFEINEMedtech Products Inc.c5fa6660-a549-49ff-ac2b-5799afa22ec52026-04-24WarningsExact identifier
application number: M013
Doans Maximum StrengthMAGNESIUM SALICYLATEDr. Reddy's Laboratories Inc.c906df41-bb45-03ea-b1a8-2b9816d55c972026-04-24WarningsExact identifier
application number: M013
Diphenhydramine HClDIPHENHYDRAMINE HCLCardinal Health 107, LLCabc0e348-8532-4658-bd8c-d7dbe5a28c7d2026-04-23WarningsExact identifier
unii: TC2D6JAD40
nitetime severeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEPublix Super Markets Incc5535aaf-c029-48d8-97d1-105a49b5fd952026-04-23WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENCamber Pharmaceuticals, Inc.1c8fef8f-2ff5-4bea-bccb-90c2c8544c212026-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Rite Aid Itch ReliefDIPHENHYDRAMINE HCL 2%, ZINC ACETATE 0.1%Rite Aide285df43-317c-d862-e053-2a95a90acdce2026-04-23WarningsExact identifier
unii: TC2D6JAD40
ALKA SELTZER COLD Cold and Flu Severe Fast ChewablesCHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEBayer HealthCare LLC.5025a333-6378-bf59-e063-6394a90af4f02026-04-23WarningsExact identifier
unii: 362O9ITL9D
ALKA SELTZER COLD Cold and Allergy Maximum Strength Fast GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.5026611c-93e7-8f90-e063-6394a90a7baa2026-04-23WarningsExact identifier
unii: 362O9ITL9D
Extra Strength AcetaminophenACETAMINOPHENTIME CAP LABORATORIES, INC.48912649-9fa1-a11f-e063-6294a90a8a722026-04-23WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Aspirin 81 mg Low DoseASPIRINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED23b29044-6389-42ea-839a-5351557a6ce32026-04-23WarningsExact identifier
application number: M013
Allergy ReliefDIPHENHYDRAMINE HCLDOLGENCORP, LLCc9c1db0f-6ba4-433c-b0ce-e99e9351c0b02026-04-23WarningsExact identifier
unii: TC2D6JAD40
Childrens Pain and FeverACETAMINOPHENCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED4a70867e-481d-4f01-9da3-d85663a1672e2026-04-23WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Aspirin Low DoseASPIRINUnited Natural Foods, Inc. dba UNFI07edcb31-d31d-4607-98c3-dcb1e062cc702026-04-22WarningsExact identifier
application number: M013
Severe Cold and Flu Night timeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLHyVee Inc4f963491-e1f0-494d-acb6-5f4d2b267d4a2026-04-22WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.