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 5 of 264 · 5,264 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Feverall ChildrensACETAMINOPHENSun Pharmaceutical Industries, Inc.861e2987-5473-45b0-b2a6-f980a9b0e8092026-08-24WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENWalgreens543f93d1-df14-0bd2-e063-6294a90a44132026-08-24WarningsExact identifier
unii: 362O9ITL9D
ACETAMINOPHENACETAMINOPHENAkron Pharma Inc.ab79fd60-8315-4c63-8045-1b0511ac268f2026-08-24WarningsExact identifier
unii: 362O9ITL9D
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
migraine reliefACETAMINOPHEN, ASPIRIN, CAFFEINEWalgreen Company36503181-0fda-4127-b3f0-bdb1b56bb0ed2026-08-24WarningsExact identifier
unii: 362O9ITL9D
Cold, Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.9be8437c-6053-4ed4-bdd2-97f556b5289e2026-08-24WarningsExact identifier
unii: 362O9ITL9D
Genexa Infants Pain and FeverACETAMINOPHENGenexa Inc.4fd048c3-70bc-2ea7-e063-6394a90a55f22026-08-22WarningsExact identifier
unii: 362O9ITL9D
Genexa Kids Pain and FeverACETAMINOPHENGenexa Inc.59adabeb-97e8-2de4-e063-6394a90acc472026-08-22WarningsExact identifier
unii: 362O9ITL9D
DG HEALTH MULTI SYMPTOM SEVERE COLDACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLDolgencorp, LLC47ddbb0d-0823-4817-9c56-e7fff77d601c2026-08-21WarningsExact identifier
unii: 362O9ITL9D
Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEPublix Super Markets Inca876daa7-ade3-497d-87bb-46d6e4dc185a2026-08-21WarningsExact identifier
unii: 362O9ITL9D
Rohto Max StrengthNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companye4b49550-1ca3-4bd7-854d-409b53fa5e262026-08-20WarningsExact identifier
unii: 6OZP39ZG8H
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
HyVee Nighttime Severe Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEHyVee Inc49818610-bf4a-fb86-e063-6294a90ae5982026-08-20WarningsExact identifier
unii: 362O9ITL9D
HyVee Daytime Severe Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEHyVee Inc496ec389-1aea-f202-e063-6394a90ae51c2026-08-20WarningsExact identifier
unii: 362O9ITL9D
CombogesicACETAMINOPHEN AND IBUPROFENPreferred Pharmaceuticals Inc.f3cee991-19ef-4a1c-bb14-cbc8b6f327762026-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEREMEDYREPACK INC.5c96d033-bf7c-47de-aa0d-5998b3bf4a632026-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINE HCLStrategic Sourcing Services LLCb3baf939-a9fd-47ac-9bc7-68435e32ea1e2026-08-19WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENSam's West Inc1098d0e7-8202-4018-a2d2-b0c80ee58b562026-08-19WarningsExact identifier
unii: 362O9ITL9D
CVS Childrens Cold plus Cough plus Runny NoseACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDECVS7dc30e46-e289-40fc-b217-b123fee5daee2026-08-19WarningsExact identifier
unii: 362O9ITL9D
nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLAmazon.com Services LLC2517b241-c433-440f-999d-5a32d5bbaa262026-08-19WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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