FDA.reportPublic FDA data

NDC 52389-153-01 - BackAid Max

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
52389-153
Requested NDC
52389-153-01
Package NDCs from labels
52389-153-01, 52389-153-28, 52389-153-14, 52389-153-03, 52389-153-38, 52389-153-46, 52389-153-35
Manufacturer
Kobayashi Healthcare International, Inc. | Kobayashi America Manufacturing, LLC
Effective date
2025-04-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
BackAidKobayashi Healthcare International, Inc. | Kobayashi America Manufacturing, LLC2025-04-14HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52389-153-01BackAidMax14 in 1 BLISTER PACKTABLET, FILM COATED1414
52389-153-03BackAidMax38 in 1 BOTTLE, PLASTICTABLET, FILM COATED3814
52389-153-14BackAidMax1 in 1 CARTONTABLET, FILM COATED114
52389-153-28BackAidMax2 in 1 CARTONTABLET, FILM COATED214
52389-153-35BackAidMax5 in 1 CARTONTABLET, FILM COATED514
52389-153-35BackAidMax7 in 1 BLISTER PACKTABLET, FILM COATED714
52389-153-38BackAidMax1 in 1 CARTONTABLET, FILM COATED114
52389-153-46BackAidMax1 in 1 CARTONTABLET, FILM COATED114
52389-153-46BackAidMax46 in 1 BOTTLETABLET, FILM COATED4614

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52389-153BACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [KOBAYASHI HEALTHCARE INTERNATIONAL, INC.]14Current NDC, Legacy NDC, 9 package rows20250416_fb9a5647-b7c9-4820-b148-91060e34cb83.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9DBACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]4
PamabromACTIVE INGREDIENTUA8U0KJM72BACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]4
AcetaminophenACTIVE MOIETY362O9ITL9DBACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]4
BROMOTHEOPHYLLINEACTIVE MOIETYFZG87K1MQ6BACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]4
Calcium sulfate dihydrateINACTIVE INGREDIENT4846Q921YMBACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]4
Cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UBACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]4
Croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48BACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]4
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GBACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]4
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8BACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOBACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]4
Magnesium oxideINACTIVE INGREDIENT3A3U0GI71GBACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]4
Magnesium silicateINACTIVE INGREDIENT9B9691B2N9BACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]4
Magnesium stearateINACTIVE INGREDIENT70097M6I30BACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]4
Mineral oilINACTIVE INGREDIENTT5L8T28FGPBACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]4
Polyethylene glycol 600INACTIVE INGREDIENTNL4J9F21N9BACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]4
Potassium gluconateINACTIVE INGREDIENT12H3K5QKN9BACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]4
PovidoneINACTIVE INGREDIENTFZ989GH94EBACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]4
Sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JBACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]4
Sodium starch glycolate type a potatoINACTIVE INGREDIENT5856J3G2A2BACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]4
SorbitolINACTIVE INGREDIENT506T60A25RBACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]4
Starch, cornINACTIVE INGREDIENTO8232NY3SJBACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]4
Stearic acidINACTIVE INGREDIENT4ELV7Z65APBACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]4
Titanium dioxideINACTIVE INGREDIENT15FIX9V2JPBACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]4

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 58 of 288 · 5,753 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acetaminophen Regular StrengthACETAMINOPHENAmerisource Bergenc280ac64-920c-4d03-9190-03e0196ed5ef2026-03-11WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Neutrogena Healthy Skin Liquid Makeup Broad Spectrum SPF 20 - Cool Bronze 440CTITANIUM DIOXIDEKenvue Brands LLC4c335d9c-40ca-c0ce-e063-6394a90ac20a2026-03-11WarningsExact identifier
unii: 15FIX9V2JP
Mucus Relief Cold, Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLTOPCO ASSOCIATES LLC6207ef50-4f28-4dbc-9a52-f44dd53d2a4f2026-03-11WarningsExact identifier
unii: 362O9ITL9D
severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDc17a10a3-6b8f-4734-8f00-1f4c5c7297252026-03-11WarningsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENAsclemed USA, Inc.66e184cd-fa32-431f-b843-9c4bea12593b2026-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Sudafed PE Sinus Pressure Plus PainACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDESportpharm LLC67428f4b-28be-4682-a9a9-781bf85089ff2026-03-10WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen 250 mg and Ibuprofen 125 mgACETAMINOPHEN 250 MG AND IBUPROFEN 125 MG TABLETSSun Pharmaceutical Industries, Inc.2a31a975-72f9-2a16-e063-6394a90a81492026-03-10WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDd79828d8-9279-4ae9-8872-aeca641be5d92026-03-10WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack806a981f-85ff-4e58-8ff0-7ab02ed2e5c12026-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Adult Low Dose Enteric Coated AspirinASPIRINPreferred Pharmaceuticals Inc.1b5b8bb1-c45d-48f0-b275-9ce1f769fed42026-03-09WarningsExact identifier
application number: M013
sinus pressure and pain and coughACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLTarget Corporation488588f3-62d3-4248-937a-1c200792b5f12026-03-09WarningsExact identifier
unii: 362O9ITL9D
foster and thrive childrens pain and feverACETAMINOPHENStrategic Sourcing Services LLCe495a27e-eb64-4c42-8942-43bab99181722026-03-07WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Butalbital, Acetaminophen, and CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINEMajor Pharmaceuticals0ca49c3c-f2cb-40e3-a7d5-5f48eca590162026-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Acetaminophen PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLCVS PHARMACY67a190c3-7de0-4f57-be94-d6b8285e12202026-03-06WarningsExact identifier
application number: M013
unii: 362O9ITL9D
foster and thrive daytime severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDESportpharm LLC51e34704-5e6b-4e80-836c-ddbc24a451b22026-03-06WarningsExact identifier
unii: 362O9ITL9D
good sense migraine formulaACETAMINOPHEN, ASPIRIN, CAFFEINESportpharm LLC2a27da49-23d6-4035-8088-806ee22b98b02026-03-06WarningsExact identifier
unii: 362O9ITL9D
Allergen IPOTASSIUM GLUCONATE, GLANDULA SUPRARENALIS BOVINE, HEPAR BOVINE, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORUS, PEANUT, BLACK WALNUT, ENGLISH WALNUT, AMYGDALA AMARA, CASHEW, COCONUT, PECAN, BRAZIL NUT, TOMATO, SOLANUM TUBEROSUM, PIPER NIGRUM, EGGPLANT (SOLANUM MELONGENA), RAPE SEED OIL, LINUM USITATISSIMUM, SESAME SEED, CHEESE (STILTON), LAC VACCINUM, BEEF, LAMB, PORK, CHICKEN, EGG (WHOLE), PHASEOLUS, ALLIUM CEPA, APPLE, WHEAT, BANANA, STRAWBERRY, COD (GADUS MORHUA), TUNA (THUNNUS THYNNUS),BioActive Nutritional25e10444-a2cc-4f74-bf38-9852c273e5ca2026-03-06WarningsExact identifier
unii: 12H3K5QKN9
hydrocodone bitartrate and acetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENEywa Pharma Inc8a201e19-3e47-7e58-e053-2995a90ab1d52026-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Back and Body Pain ReliefASPIRIN, CAFFEINEWinCo Foods, LLCcf5c15e9-c45d-4bd6-a887-fd74de5f81b92026-03-06WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENTopco Associates, LLC87af092c-99e6-475d-81af-b9fd8fc337d72026-03-06WarningsExact identifier
application number: M013
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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