FDA.reportPublic FDA data

NDC 65862-922-10 - Tramadol Hydrochloride and Acetaminophen

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
65862-922
Requested NDC
65862-922-10
Package NDCs from labels
65862-922-30, 65862-922-01, 65862-922-05, 65862-922-99, 65862-922-10, 65862-922-78
Manufacturer
REMEDYREPACK INC.
Effective date
2026-09-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Tramadol Hydrochloride and Acetaminophen - REMEDYREPACK INC.REMEDYREPACK INC.2026-09-11HUMAN PRESCRIPTION DRUG LABEL
Tramadol Hydrochloride and Acetaminophen - St. Mary's Medical Park PharmacySt. Mary's Medical Park Pharmacy2026-06-30HUMAN PRESCRIPTION DRUG LABEL
Tramadol Hydrochloride and Acetaminophen - Bryant Ranch PrepackBryant Ranch Prepack2026-05-14HUMAN PRESCRIPTION DRUG LABEL
Tramadol Hydrochloride and Acetaminophen - Bryant Ranch PrepackBryant Ranch Prepack2026-03-13HUMAN PRESCRIPTION DRUG LABEL
Tramadol Hydrochloride and Acetaminophen - Aurobindo Pharma LimitedAurobindo Pharma Limited2025-11-17Human Prescription Drug Label
Tramadol Hydrochloride and Acetaminophen - Direct_RxDirect_Rx2025-01-22HUMAN PRESCRIPTION DRUG LABEL
STARCH, CORN - Medsource Pharmaceuticals | Aurobindo Pharma LimitedMedsource Pharmaceuticals | Aurobindo Pharma Limited2024-03-05HUMAN PRESCRIPTION DRUG LABEL
Tramadol Hydrochloride and Acetaminophen - NuCare Pharmaceuticals,Inc.NuCare Pharmaceuticals,Inc.2022-10-06HUMAN PRESCRIPTION DRUG LABEL
Tramadol Hydrochloride and Acetaminophen - Proficient Rx LPProficient Rx LP2022-06-01HUMAN PRESCRIPTION DRUG LABEL
Tramadol Hydrochloride and Acetaminophen - A-S Medication SolutionsA-S Medication Solutions2018-08-27Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-922-01Tramadol Hydrochloride and Acetaminophen100 in 1 BOTTLETABLET, FILM COATED10015
65862-922-05Tramadol Hydrochloride and Acetaminophen500 in 1 BOTTLETABLET, FILM COATED50015
65862-922-10Tramadol Hydrochloride and Acetaminophen10 in 1 BLISTER PACKTABLET, FILM COATED1015
65862-922-30Tramadol Hydrochloride and Acetaminophen30 in 1 BOTTLETABLET, FILM COATED3015
65862-922-78Tramadol Hydrochloride and Acetaminophen10 in 1 CARTONTABLET, FILM COATED1015
65862-922-99Tramadol Hydrochloride and Acetaminophen1000 in 1 BOTTLETABLET, FILM COATED100015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-922TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]12Current NDC, Legacy NDC, 6 package rows20240112_6c2894df-eeeb-4b22-ab32-8ce1601bfdfa.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-922-01EA - Each65862-922187e057e-9e3b-4c50-b719-2cf92223efb812017-07-07
65862-922-05EA - Each65862-922f68335de-1d02-4237-87a5-9f0a56f3684a12017-07-07

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 1 of 273 · 5,455 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COLTALIN-DMACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEFORTUNE PHARMACAL COMPANY LIMITED33e1bec0-323b-40b7-809a-cb65a71ad0ce2026-09-17WarningsExact identifier
unii: 362O9ITL9D
Cold and Flu HBPACETAMINOPHEN, CHLORPHENIRAMINE MALEATEKroger Companyfd41e4a4-330f-4409-8ba3-0b3bb6f45bca2026-09-10WarningsExact identifier
unii: 362O9ITL9D
childrens fever reducer and pain relieverACETAMINOPHENRite Aid Corporation7f445de3-30cf-4bd8-892d-05979cd399e72026-09-09WarningsExact identifier
unii: 362O9ITL9D
dual actionACETAMINOPHEN, IBUPROFENRite Aid Corporation54b08d24-d5e9-4111-9d97-329896e8309d2026-09-09WarningsExact identifier
unii: 362O9ITL9D
Mucus Relief Cold Flu and Sore Throat Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRaritan Pharmaceuticals Inc2cb3e17f-3858-4773-a53f-0860ae6ff1b92026-09-09WarningsExact identifier
unii: 362O9ITL9D
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDERite Aid Corporation4b8ae971-ab57-4937-a878-72d905d7b8492026-09-09WarningsExact identifier
unii: 362O9ITL9D
Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCARDINAL HEALTH 110, LLC. DBA LEADER 7000082ba9a73-60ef-49fd-960f-5ca2bb79555e2026-09-09WarningsExact identifier
unii: 362O9ITL9D
DRx Choice maximum strength Severe Cough plus sore throatACETAMINOPHEN, DEXTROMETHORPHAN HBRRARITAN PHARMACEUTICALSa096cb76-0d1c-4ca8-854a-5199da0bc8f72026-09-09WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen Extra StrengthACETAMINOPHENWal-Mart Stores Inc78874258-16cc-40b5-9e15-5943eddfce942026-09-08WarningsExact identifier
unii: 362O9ITL9D
Vicks DayQuil VapoCOOL SEVERE COLD and FLU plus CONGESTIONACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Companyefb69cc1-a745-6efc-e053-2a95a90abdc92026-09-08WarningsExact identifier
unii: 362O9ITL9D
Vicks NyQuil VapoCOOL Severe COLD and FLU plus CONGESTIONACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDEThe Procter & Gamble Manufacturing Companyefb5f0b9-9825-ab23-e053-2995a90a26ab2026-09-08WarningsExact identifier
unii: 362O9ITL9D
Overnight Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLRARITAN PHARMACEUTICALSeef00453-9f4f-4a05-bb4e-49b94705b52c2026-09-08WarningsExact identifier
unii: 362O9ITL9D
Pain and Fever ChildrensACETAMINOPHENDOLGENCORP, LLCc637b39c-a049-43af-a582-fc242e940d852026-09-08WarningsExact identifier
unii: 362O9ITL9D
Nighttime Severe Cold and CoughACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINERARITAN PHARMACEUTICALS INC9819155b-2713-42be-867e-16605e7643d02026-09-08WarningsExact identifier
unii: 362O9ITL9D
Pain Reliever Extra StrengthACETAMINOPHENWalgreen Companyf7667529-09c0-4603-8080-f236144fac362026-09-08WarningsExact identifier
unii: 362O9ITL9D
UP AND UP CHILDRENS ACETAMINOPHENACETAMINOPHENTarget Corporatione2989ead-7fdc-4295-bf94-4231957756702026-09-08WarningsExact identifier
unii: 362O9ITL9D
Cold and Flu HBPACETAMINOPHEN, CHLORPHENIRAMINE MALEATEWALMART INC.f9d1dfd1-527f-491d-9188-14886ac70ced2026-09-08WarningsExact identifier
unii: 362O9ITL9D
Pain Relief Extra StrengthACETAMINOPHENRite Aid Corporationd846065a-5c39-4f4b-894c-4280acaaf4fa2026-09-08WarningsExact identifier
unii: 362O9ITL9D
severe cold and cough daytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDERARITAN PHARMACEUTICALS INC3ce8508e-7d9d-4413-858a-8f952e760c012026-09-08WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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