FDA.reportPublic FDA data

NDC 50268-774-11 - 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
50268-774
Requested NDC
50268-774-11
Package NDCs from labels
50268-774-11, 50268-774-15
Manufacturer
AvPAK
Effective date
2026-01-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Tramadol Hydrochloride and Acetaminophen - AvPAKAvPAK2026-01-12HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50268-774-11Tramadol Hydrochloride and Acetaminophen1 in 1 BLISTER PACKTABLET16
50268-774-15Tramadol Hydrochloride and Acetaminophen50 in 1 BOXTABLET506

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-774TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AVPAK]5Current NDC, Legacy NDC, 2 package rows20240110_244f6e5d-e1b4-ba8b-ca6f-af2d8a31d5f0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-774-11EA - Each50268-774e8239951-49d3-40ca-9ed1-1e711a3a6d0612015-06-09
50268-774-15EA - Each50268-7747693438f-eae2-4d66-b3eb-efc8d3e422ce12015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AVPAK]1
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AVPAK]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AVPAK]1
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AVPAK]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AVPAK]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AVPAK]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AVPAK]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AVPAK]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AVPAK]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AVPAK]1
Polyethylene GlycolsINACTIVE INGREDIENT3WJQ0SDW1ATRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AVPAK]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AVPAK]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ETRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AVPAK]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AVPAK]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AVPAK]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AVPAK]1
TALCINACTIVE INGREDIENT7SEV7J4R1UTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AVPAK]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AVPAK]1

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 · 5,454 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
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: 532B59J990
unii: FZ989GH94E
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

Reported adverse events (FAERS/openFDA)#

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