FDA.reportPublic FDA data

NDC 0135-0607-01 - Panadol Cold and Flu NonDrowsy

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
0135-0607
Requested NDC
0135-0607-01
Package NDCs from labels
0135-0607-01, 0135-0607-03, 0135-0607-02
Manufacturer
Haleon US Holdings LLC
Effective date
2024-02-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Panadol Cold and Flu NonDrowsy - Haleon US Holdings LLCHaleon US Holdings LLC2024-02-06HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0135-0607-022020-07-22C16284748780-1ab0e2407-34ee-f274-e053-dbdaa90a6471Drug Facts
0135-0607-032020-07-22C16284748780-1ab0e2407-34ee-f274-e053-dbdaa90a6471Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0607-01PanadolCold and Flu NonDrowsy2 in 1 PACKETTABLET, FILM COATED26
0135-0607-02PanadolCold and Flu NonDrowsy3 in 1 CARTONTABLET, FILM COATED36
0135-0607-02PanadolCold and Flu NonDrowsy8 in 1 BLISTER PACKTABLET, FILM COATED86
0135-0607-03PanadolCold and Flu NonDrowsy50 in 1 CARTONTABLET, FILM COATED506

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0607PANADOL COLD AND FLU NONDROWSY (ACETAMINOPHEN AND PHENYLEPRINE HCL) TABLET, FILM COATED [HALEON US HOLDINGS LLC]6Current NDC, Legacy NDC, 4 package rows20240207_f626ab17-01c9-4493-ba9e-0c8c11146384.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0607-02EA - Each0135-06073d20babd-8f09-4f9a-a49a-c498993637c612022-12-07

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 26 of 305 · 6,091 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sinus CongestionPHENYLEPHRINE HCLChain Drug Marketing Association, Inc.43a77f89-e66a-4db6-8067-f614c0e207df2026-06-16WarningsExact identifier
unii: 04JA59TNSJ
Pain Relief Extra StrengthACETAMINOPHENDOLGENCORP, LLCce9f4e0d-43fb-499a-b8a2-a997a14841c42026-06-16WarningsExact identifier
application number: M013
unii: 362O9ITL9D
severe sinus congestion relief Maximum StrengthACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporation51175d3e-e1c3-4e4d-ad32-61600e87568c2026-06-16WarningsExact identifier
unii: 04JA59TNSJ
unii: 362O9ITL9D
foster and thrive daytime cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLStrategic Sourcing Services LLC067ce5de-dbb4-4b65-8ec0-f4aacbe5e0a62026-06-16WarningsExact identifier
unii: 04JA59TNSJ
unii: 362O9ITL9D
Equate Severe Cold Cough and FluACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEWALMART INC.a35531d7-1a96-45cb-922f-61db085cde1f2026-06-16WarningsExact identifier
unii: 362O9ITL9D
Pain RelieverACETAMINOPHENL.N.K. International, Inc.734cc3d2-6fc5-4dcc-93ed-0b57c1f013452026-06-15WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Pain Relief Sinus CongestionACETAMINOPHEN, PHENYLEPHRINE HCLBetter Living Brands, LLC1d3d6397-0d92-4145-9a70-8bcc45bd03222026-06-15WarningsExact identifier
rxcui: 1046378
unii: 04JA59TNSJ
unii: 362O9ITL9D
RIGHT REMEDIES EXTRA STRENGTH Pain Relief PM CapletACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Inc.2d63671d-cf7c-bbdd-e063-6294a90affef2026-06-15WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Shield by HEALTHY SKIN LAB MD SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEHEALTHY SKIN LAB LIMITED6838b754-9915-48ff-af35-5338dbd06ac42026-06-15WarningsExact identifier
unii: 15FIX9V2JP
ACETAMINOPHENACETAMINOPHENGranules India Limited00eb3e4b-1507-4c9a-83a5-ef50cb3127532026-06-15WarningsExact identifier
unii: 362O9ITL9D
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLC59773893-09a8-47a2-943a-e9ea9da4458a2026-06-15WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Pain ReliefACETAMINOPHENShield Pharmaceuticals Corp.96eb7f9f-ff2d-4661-bbe6-1860aafe03f62026-06-15WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Duralgina Extra StrengthACETAMINOPHENMenper Distributors, Inc.544e3d7e-a759-384f-e063-6294a90a5baa2026-06-15WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENSt. Mary's Medical Park Pharmacy3cd1cb17-4aea-a750-e063-6394a90a95942026-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENSt. Mary's Medical Park Pharmacy3cd2e535-dd11-4bfb-e063-6394a90a9fbc2026-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENSt. Mary's Medical Park Pharmacy3d3292f0-93b5-1fd0-e063-6294a90a37162026-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
pain relief childrensACETAMINOPHENRite Aid Corporationbe2286a1-946b-4bf5-b14c-8e86da6695942026-06-15WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Aspirin 81ASPIRINAmerisource Bergen4491faca-f30b-4eb0-bea9-f518f6b2f0952026-06-15WarningsExact identifier
application number: M013
SFL SUNSCREEN - SOL DEFENSE SPF 30TITANIUM DIOXIDE, ZINC OXIDELifeline Medical, Inc5438c185-31c9-c51e-e063-6394a90ae9ef2026-06-14WarningsExact identifier
unii: 15FIX9V2JP
Natucure HEMORRHOIDLIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOIDJiangxi Yudexi Pharmaceutical Co., LTD49e402ed-d314-e896-e063-6294a90a826b2026-06-14WarningsExact identifier
unii: 04JA59TNSJ

Reported adverse events (FAERS/openFDA)#

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