Home NDC 67091-119 Childrens Pain Relief Dye-Free
Product NDC 67091-119
11-digit product format 670910119
Labeler code 67091
Product ID 67091-119_407e049c-266e-4ecf-9a59-f4f77aace291
Type HUMAN OTC DRUG
Nonproprietary name Acteaminophen
Dosage form SUSPENSION
Route ORAL
Labeler WinCo Foods, LLC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-12-12
Substance ACETAMINOPHEN
Active strength 160 mg/5mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Childrens Pain Relief Dye-Free
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 160 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 307668 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67091-119-18 Childrens Pain Relief Dye-Free 1 in 1 CARTON SUSPENSION 1 6 67091-119-18 Childrens Pain Relief Dye-Free 118 mL in 1 BOTTLE SUSPENSION 118 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D CHILDRENS PAIN RELIEF DYE-FREE (ACTEAMINOPHEN) SUSPENSION [WINCO FOODS, LLC] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D CHILDRENS PAIN RELIEF DYE-FREE (ACTEAMINOPHEN) SUSPENSION [WINCO FOODS, LLC] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL CHILDRENS PAIN RELIEF DYE-FREE (ACTEAMINOPHEN) SUSPENSION [WINCO FOODS, LLC] 1 BUTYLPARABEN INACTIVE INGREDIENT 3QPI1U3FV8 CHILDRENS PAIN RELIEF DYE-FREE (ACTEAMINOPHEN) SUSPENSION [WINCO FOODS, LLC] 1 CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 50-100 MPA.S AT 1%) INACTIVE INGREDIENT 6QM647NAYU CHILDRENS PAIN RELIEF DYE-FREE (ACTEAMINOPHEN) SUSPENSION [WINCO FOODS, LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CHILDRENS PAIN RELIEF DYE-FREE (ACTEAMINOPHEN) SUSPENSION [WINCO FOODS, LLC] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX CHILDRENS PAIN RELIEF DYE-FREE (ACTEAMINOPHEN) SUSPENSION [WINCO FOODS, LLC] 1 MALTITOL INACTIVE INGREDIENT D65DG142WK CHILDRENS PAIN RELIEF DYE-FREE (ACTEAMINOPHEN) SUSPENSION [WINCO FOODS, LLC] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 CHILDRENS PAIN RELIEF DYE-FREE (ACTEAMINOPHEN) SUSPENSION [WINCO FOODS, LLC] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH CHILDRENS PAIN RELIEF DYE-FREE (ACTEAMINOPHEN) SUSPENSION [WINCO FOODS, LLC] 1 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 CHILDRENS PAIN RELIEF DYE-FREE (ACTEAMINOPHEN) SUSPENSION [WINCO FOODS, LLC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R CHILDRENS PAIN RELIEF DYE-FREE (ACTEAMINOPHEN) SUSPENSION [WINCO FOODS, LLC] 1 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE CHILDRENS PAIN RELIEF DYE-FREE (ACTEAMINOPHEN) SUSPENSION [WINCO FOODS, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67091-119 CHILDRENS PAIN RELIEF DYE-FREE (ACTEAMINOPHEN) SUSPENSION [WINCO FOODS, LLC] 6 Current NDC, Legacy NDC, 2 package rows 20240413_5ee134b3-b8e9-4621-b0a1-a84d9867ccba.zip
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 64 of 79 · 1,579 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 67091-119-18 67091011918 1 BOTTLE in 1 CARTON (67091-119-18) / 118 mL in 1 BOTTLE 1 bottle 2014-12-12 0000-00-00 No No Current