FDA.reportPublic FDA data

NDC 0498-2102-01 - BACK RELIEF

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
0498-2102
Requested NDC
0498-2102-01
Package NDCs from labels
0498-2102-01, 0498-2102-10
Manufacturer
Honeywell Safety Products USA, Inc | NORTH SAFETY DE MEXICALI, S. DE R.I. DE C.V.
Effective date
2021-12-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
0498-2102 & 0498-2101: Back ReliefHoneywell Safety Products USA, Inc | NORTH SAFETY DE MEXICALI, S. DE R.I. DE C.V.2021-12-09HUMAN OTC DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DBACK RELIEF (ACETAMINOPHEN, MAGNESIUM SALICYLATE) TABLET [NORTH SAFETY PRODUCTS LLC]1
MAGNESIUM SALICYLATEACTIVE INGREDIENT41728CY7UXBACK RELIEF (ACETAMINOPHEN, MAGNESIUM SALICYLATE) TABLET [NORTH SAFETY PRODUCTS LLC]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DBACK RELIEF (ACETAMINOPHEN, MAGNESIUM SALICYLATE) TABLET [NORTH SAFETY PRODUCTS LLC]1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZBACK RELIEF (ACETAMINOPHEN, MAGNESIUM SALICYLATE) TABLET [NORTH SAFETY PRODUCTS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBACK RELIEF (ACETAMINOPHEN, MAGNESIUM SALICYLATE) TABLET [NORTH SAFETY PRODUCTS LLC]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHBACK RELIEF (ACETAMINOPHEN, MAGNESIUM SALICYLATE) TABLET [NORTH SAFETY PRODUCTS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBACK RELIEF (ACETAMINOPHEN, MAGNESIUM SALICYLATE) TABLET [NORTH SAFETY PRODUCTS LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBACK RELIEF (ACETAMINOPHEN, MAGNESIUM SALICYLATE) TABLET [NORTH SAFETY PRODUCTS LLC]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 53 of 152 · 3,021 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gencare DayTime Cold and Flu SoftgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEPioneer Life Sciences, LLCa9875dc9-6a27-413c-a2c7-68a86483ffc12025-12-26WarningsExact identifier
unii: 362O9ITL9D
GenCare Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEPioneer Life Sciences, LLC667f6f1b-5179-481c-a131-940c7937aada2025-12-26WarningsExact identifier
unii: 362O9ITL9D
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENRedPharm Drug2c6014de-8901-9d83-e063-6294a90ad37b2025-12-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
PharbetolACETAMINOPHENPharbest Pharmaceuticals, Inc.04dbd98f-c74d-43b2-8bda-74f18be7cf6c2025-12-24WarningsExact identifier
unii: 362O9ITL9D
CETAFEN EXTRAACETAMINOPHENHART Health38db0b09-37f8-4fed-903e-81e89486b39b2025-12-24WarningsExact identifier
unii: 362O9ITL9D
CETAFENACETAMINOPHENHART Healthc1162bab-377d-4e17-9417-ccd20d29148b2025-12-24WarningsExact identifier
unii: 362O9ITL9D
CETAFEN COUGH and COLDACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL , GUAIFENESIN, ,HART Health44da0d8c-4a12-4122-99da-781e2809e1a82025-12-24WarningsExact identifier
unii: 362O9ITL9D
Pharbetol Regular strengthACETAMINOPHENPharbest Pharmaceuticals, Inc.e0a39957-d918-4125-88f9-0e550b976fa12025-12-24WarningsExact identifier
unii: 362O9ITL9D
PHARBETOLACETAMINOPHEN 500MGPharbest Pharmaceuticals, Inc.27337be9-e279-460e-903e-ae44630995992025-12-24WarningsExact identifier
unii: 362O9ITL9D
SAFETUSSIN MAX STRENGTH MS Cough, Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESINKRAMER LABORATORIES920bde5f-4079-45de-aa59-24b00e50cb562025-12-23WarningsExact identifier
unii: 362O9ITL9D
Daytime Cold and FluACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDEHumanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd46996bbf-948c-0aba-e063-6394a90a09e32025-12-23WarningsExact identifier
unii: 362O9ITL9D
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATELil' Drug Store Products, Inc.1d2e2a5a-099b-41b3-82bd-5bf704377f782025-12-23WarningsExact identifier
unii: 362O9ITL9D
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDELil' Drug Store Products, Inc.5b493ed7-9044-4841-9935-236d0bdc71a92025-12-23WarningsExact identifier
unii: 362O9ITL9D
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDELil' Drug Store Products, Inc.77a7ff9a-a414-4053-8d8d-369907d4380d2025-12-23WarningsExact identifier
unii: 362O9ITL9D
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATELil' Drug Store Products, Inc.8f320235-f243-4211-b99c-18526e6865482025-12-23WarningsExact identifier
unii: 362O9ITL9D
Circle K Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDELil' Drug Store Products, Inc.b6a46498-d9a8-4da2-9283-57d135f305a52025-12-23WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENCVS PHARMACY INCbd8ce39f-ccf8-3976-e053-2a95a90abb1f2025-12-23WarningsExact identifier
unii: 362O9ITL9D
Circle K Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATELil' Drug Store Products, Inc.7c5faec2-28c6-4c15-a268-d8b578140b742025-12-23WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENPUBLIX SUPERMARKETS, INC08f5af1d-365b-a97c-e063-6394a90a99ae2025-12-23WarningsExact identifier
unii: 362O9ITL9D
ACETAMINOPHEN 500 MGACETAMINOPHENPioneer Life Sciences, LLC0d67bb52-7ae3-439e-9e47-4e21eb0ca3522025-12-23WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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