FDA.reportPublic FDA data

NDC 42571-119-32 - 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
42571-119
Requested NDC
42571-119-32
Package NDCs from labels
42571-119-01, 42571-119-05, 42571-119-32, 42571-119-23, 42571-119-90
Manufacturer
Micro Labs Limited
Effective date
2025-12-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN - Micro Labs LimitedMicro Labs Limited2025-12-22HUMAN PRESCRIPTION DRUG LABEL
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN - REMEDYREPACK INC.REMEDYREPACK INC.2022-02-02HUMAN PRESCRIPTION DRUG LABEL
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN - Preferred Pharmaceuticals, Inc.Preferred Pharmaceuticals, Inc.2021-09-21HUMAN PRESCRIPTION DRUG LABEL
STARCH, CORN - Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEMAsclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM2020-10-30HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42571-119-01TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN100 in 1 BOTTLETABLET, FILM COATED10028
42571-119-05TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN500 in 1 BOTTLETABLET, FILM COATED50028
42571-119-23TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN8 in 1 CARTONTABLET, FILM COATED828
42571-119-32TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN10 in 1 BLISTER PACKTABLET, FILM COATED1028
42571-119-90TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN90 in 1 BOTTLETABLET, FILM COATED9028

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42571-119TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN) TABLET, FILM COATED [MICRO LABS LIMITED]27Legacy NDC, 5 package rows20231228_ab84058e-e52c-4b81-badc-4b0c26aab259.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42571-119-01EA - Each42571-119ca1cbd33-5f32-41c4-bab7-ead0ef80c66312013-07-02
42571-119-05EA - Each42571-119fd47a9a1-7410-425d-a3ef-442d09d7f58c12013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [MICRO LABS LIMITED]15
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [MICRO LABS LIMITED]15
ACETAMINOPHENACTIVE MOIETY362O9ITL9DTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [MICRO LABS LIMITED]15
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [MICRO LABS LIMITED]15
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [MICRO LABS LIMITED]15
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [MICRO LABS LIMITED]15
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [MICRO LABS LIMITED]15
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [MICRO LABS LIMITED]15
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [MICRO LABS LIMITED]15
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [MICRO LABS LIMITED]15
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [MICRO LABS LIMITED]15
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [MICRO LABS LIMITED]15
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [MICRO LABS LIMITED]15
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [MICRO LABS LIMITED]15

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 264 · 5,267 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daytime Sinus SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLKroger Company1022767d-a456-4fbc-95cf-91337c74c3302026-10-01WarningsExact identifier
unii: 362O9ITL9D
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

Reported adverse events (FAERS/openFDA)#

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