FDA.reportPublic FDA data

NDC 0498-7000-01 - Fem 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
0498-7000
Requested NDC
0498-7000-01
Package NDCs from labels
0498-7000-01, 0498-7000-10, 0498-7000-25, 0498-7000-50
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
0498-7001 & 0498-7000: Fem 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 INGREDIENT362O9ITL9DFEM RELIEF (ACETAMINOPHEN PAMABROM ) TABLET [NORTH SAFETY PRODUCTS LLC]1
PAMABROMACTIVE INGREDIENTUA8U0KJM72FEM RELIEF (ACETAMINOPHEN PAMABROM ) TABLET [NORTH SAFETY PRODUCTS LLC]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DFEM RELIEF (ACETAMINOPHEN PAMABROM ) TABLET [NORTH SAFETY PRODUCTS LLC]1
PAMABROMACTIVE MOIETYUA8U0KJM72FEM RELIEF (ACETAMINOPHEN PAMABROM ) TABLET [NORTH SAFETY PRODUCTS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFEM RELIEF (ACETAMINOPHEN PAMABROM ) TABLET [NORTH SAFETY PRODUCTS LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GFEM RELIEF (ACETAMINOPHEN PAMABROM ) TABLET [NORTH SAFETY PRODUCTS LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDFEM RELIEF (ACETAMINOPHEN PAMABROM ) TABLET [NORTH SAFETY PRODUCTS LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAFEM RELIEF (ACETAMINOPHEN PAMABROM ) TABLET [NORTH SAFETY PRODUCTS LLC]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EFEM RELIEF (ACETAMINOPHEN PAMABROM ) TABLET [NORTH SAFETY PRODUCTS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFEM RELIEF (ACETAMINOPHEN PAMABROM ) TABLET [NORTH SAFETY PRODUCTS LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APFEM RELIEF (ACETAMINOPHEN PAMABROM ) TABLET [NORTH SAFETY PRODUCTS LLC]1
SUCROSEINACTIVE INGREDIENTC151H8M554FEM RELIEF (ACETAMINOPHEN PAMABROM ) 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 8 of 158 · 3,147 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lipo-ChordACETICUM AC, ACETYLSAL AC, ADRENOCORTICOTROPHIN, ALUMINA, ARSENICUM ALB, BORAGO, CEANOTHUS, CHELIDONIUM MAJ, CHIONANTHUS, CHLORAMPHENICOLUM, CHLORPROMAZINUM, CHOLESTERINUM, CORTISONE ACETICUM, DAMIANA, FOLLICULINUM, FUMARICUM AC, KALI IOD, LYCOPODIUM, NAT SULPHURICUM, NUX VOM, OLEUM MORRHUAE, PETROLEUM, PHENACETINUM, PHOSPHORICUM AC, PHOSPHORUS, PLUMB MET, SACCHARUM OFF, SILICEA, TARAXACUM, THYROIDINUM.Energetix Corporation5c83cbd5-46fb-48a0-a739-ff9c81e7129c2026-08-11WarningsExact identifier
unii: C151H8M554
Daytime Cold and Flu mini SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLShield Pharmaceuticals Corpeff114fe-fb15-48dd-b673-4d4d66406e692026-08-10WarningsExact identifier
unii: 362O9ITL9D
GenCare Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEPioneer Life Sciences, LLCac8c4bdf-30c9-2b09-e053-2a95a90a9b672026-08-09WarningsExact identifier
unii: 362O9ITL9D
WINCO Maximum StrengthCold Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWINCO FOODS, LLCf34bfb71-2c81-44d0-a2a0-4d320c43c2172026-08-07WarningsExact identifier
unii: 362O9ITL9D
Severe Cold and Cough DaytimeACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINEWinCo Foods, LLC790d534a-0f40-495b-a815-67851ac3d20d2026-08-07WarningsExact identifier
unii: 362O9ITL9D
berkley and jensen acetaminophenACETAMINOPHENBJWCdee57d73-73ac-48bb-b1da-9971f1ff21c42026-08-07WarningsExact identifier
unii: 362O9ITL9D
Sinus PE Pressure plus Pain MAXIMUM STRENGTHACETAMINOPHEN, PHENYLEPHRINE HCLCVS Pharmacya3b073b4-494c-4531-b08e-475c86ba321d2026-08-07WarningsExact identifier
unii: 362O9ITL9D
Severe Cold and Cough NighttimeACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINEWinCo Foods, LLCdc56197c-c108-4b35-b791-dde5c3384ddd2026-08-07WarningsExact identifier
unii: 362O9ITL9D
Sinus Severe Non Drowsy, DaytimeACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.84c30ec9-a7b5-4d2f-95b2-d6fb895945de2026-08-07WarningsExact identifier
unii: 362O9ITL9D
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLSalado Sales, Inc.aef30709-f33d-48ff-b2d4-0639ffbd1ffd2026-08-07WarningsExact identifier
unii: 362O9ITL9D
Allergy Multi-SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICEf311b56f-b959-4070-9b23-82c642dd98b82026-08-06WarningsExact identifier
unii: 362O9ITL9D
NalocetOXYCODONE AND ACETAMINOPHENForte Bio-Pharma LLCf5f7dfca-a5c7-4445-8a5e-9ec62f33f5be2026-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
butalbital and acetaminophenBUTALBITAL AND ACETAMINOPHENPar Healthe619b656-4123-4878-b601-b0edad3c428b2026-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEPAI Holdings, LLC dba PAI Pharma95ac6875-6b14-4cde-8efb-80704e39b8d82026-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Acetaminophen, Dextromethorphan HBrACETAMINOPHEN, DEXTROMETHORPHAN HBRNUVICARE LLC6713fdff-0e4e-4a9d-b218-34f786339c572026-08-06WarningsExact identifier
unii: 362O9ITL9D
Tension Headache Aspirin-FreeACETAMINOPHEN, CAFFEINERite Aid Corporation093a7c26-f2b1-4416-b193-81133d247d2e2026-08-06WarningsExact identifier
unii: 362O9ITL9D
Menstrual Relief Maximum StrengthACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATEARMY AND AIR FORCE EXCHANGE SERVICE8282cb5a-6c38-4500-93bb-461e4d65df1c2026-08-05WarningsExact identifier
unii: UA8U0KJM72
unii: 362O9ITL9D
TOPCARE DAY TIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDETopco Associates LLCd1b89d17-b3b9-4133-88a3-8cd7c4efafa92026-08-05WarningsExact identifier
unii: 362O9ITL9D
ACETAMINOPHENACETAMINOPHENKroger Companybc17b2e5-4828-6a2e-e053-2995a90a8c632026-08-05WarningsExact identifier
unii: 362O9ITL9D
Infants TYLENOLACETAMINOPHENKenvue Brands LLC997b9551-c222-4a9c-8ba1-09a5f97495fa2026-08-05WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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