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 2 of 264 · 5,264 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
severe cold and cough daytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDERARITAN PHARMACEUTICALS INC3ce8508e-7d9d-4413-858a-8f952e760c012026-09-08WarningsExact identifier
unii: 362O9ITL9D
Multi Symptom Severe ColdACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLRARITAN PHARMACEUTICALS INCd9606c9a-31b1-4121-9870-809a05f5b68a2026-09-08WarningsExact identifier
unii: 362O9ITL9D
DESENFRIOL-ITO PLUSACETAMINOPHENOPMX LLC5ac41edd-e845-734d-e063-6294a90a990a2026-09-05WarningsExact identifier
unii: 362O9ITL9D
DRX CHOICE Regular StrengthACETAMINOPHENRaritan Pharmaceuticals Inc.8bacb24a-24d0-4175-b3e0-05efb5f5d3732026-09-05WarningsExact identifier
unii: 362O9ITL9D
Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.49235f4f-e661-4a83-88ef-b9a9568487772026-09-04WarningsExact identifier
unii: 362O9ITL9D
NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEAmazon.com Services LLC774d2bde-9f57-4ced-800a-cada39c685ed2026-09-04WarningsExact identifier
unii: 362O9ITL9D
Butalbital, Acetaminophen, CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINEREMEDYREPACK INC.dc2bb7fc-1722-4865-a02c-be5e5c2115052026-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Feverall Jr. StrengthACETAMINOPHENSun Pharmaceutical Industries, Inc.3561bbc3-53b0-4857-8b71-39e165ed95ce2026-09-03WarningsExact identifier
unii: 362O9ITL9D
Dr.Harry EYES PROTECTIONPOLYETHYLENE GLYCOL 400 1% EYES PROTECTIONWenzhou Yuyuan Pharmaceutical Co., Ltd.5a9fe033-89d3-da62-e063-6294a90a45032026-09-03WarningsExact identifier
unii: B697894SGQ
infants pain and feverACETAMINOPHENCVS Pharmacy53b06c48-598e-41ad-ac7a-5508c195535c2026-09-03WarningsExact identifier
unii: 362O9ITL9D
AMAZON BASIC CARE ACETAMINOPHENACETAMINOPHENAmazon.com Services LLC113d92bf-f6c9-cc3d-e063-6294a90af0332026-09-02WarningsExact identifier
unii: 362O9ITL9D
Childrens Multi Symptom Fever and ColdACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLTHE KROGER CO.3daf7620-eb57-43d5-ba88-938b7221e3462026-09-02WarningsExact identifier
unii: 362O9ITL9D
Extra Strength Pain RelieverACETAMINOPHENShield Pharmaceuticals Corp.78052120-40d8-4a3f-b72f-cc78ca76213b2026-09-02WarningsExact identifier
unii: 362O9ITL9D
Nighttime Cold and Flu Multi Symptom ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEShield Pharmaceuticals Corpdecafa3a-3734-4161-bab0-1219458818462026-09-02WarningsExact identifier
unii: 362O9ITL9D
Nighttime Severe Cold and CoughACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINEKROGER COMPANY7def6781-0881-46bf-ad7a-7a3f23a8d9f72026-09-02WarningsExact identifier
unii: 362O9ITL9D
Maximum Strength Cold Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLKROGER COMPANYe1d27123-358f-4b0c-8e3b-33474750a0e62026-09-02WarningsExact identifier
unii: 362O9ITL9D
Kroger Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEKroger Companyc5ce0901-a5d7-46c4-8492-5a80c76e85172026-09-02WarningsExact identifier
unii: 362O9ITL9D
Maximum Strength Nighttime Cold and FluACETAMINOPHEN , DIPHENHYDRAMINE HCL,PHENYLEPHRINE HCLTHE KROGER CO058b2021-8a61-40b0-8a2e-a784d2b847fb2026-09-02WarningsExact identifier
unii: 362O9ITL9D
Daytime Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, GUAIFENESIN PHENYLEPHRINE HCLThe Kroger Co.494e69ef-dc9f-4e14-b856-5eaf0f541a032026-09-02WarningsExact identifier
unii: 362O9ITL9D
tramadol hydrochlorideTRAMADOL HYDROCHLORIDEREMEDYREPACK INC.c6104e62-5b2c-41a1-afb3-00dcf267a3842026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK

Reported adverse events (FAERS/openFDA)#

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