Home NDC 37808-285-04 Pain Relief
Product NDC 37808-285
Requested package NDC 37808-285-04
11-digit product format 378080285
Labeler code 37808
Product ID 37808-285_42d7e3fa-9d92-4876-8eba-80d7b0cec859
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form SUSPENSION
Route ORAL
Labeler H E B
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2017-04-30
Substance ACETAMINOPHEN
Active strength 160 mg/5mL
NDC exclude flag No
Listing certified through 2026-12-31
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 Pain Relief
Brand name suffix Childrens Dye Free
Listing expiration 2026-12-31 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 Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 37808-285-04 Pain ReliefChildrens Dye Free 118 mL in 1 BOTTLE, PLASTIC SUSPENSION 118 6 37808-285-04 Pain ReliefChildrens Dye Free 1 in 1 BOX SUSPENSION 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 37808-285 PAIN RELIEF CHILDRENS DYE FREE (ACETAMINOPHEN) SUSPENSION [H E B] 6 Current NDC, Legacy NDC, 2 package rows 20240404_3f9beeeb-5e27-4b81-a647-20e65f0e9fc9.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 1 of 83 · 1,657 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 37808-285-04 37808028504 1 BOTTLE, PLASTIC in 1 BOX (37808-285-04) / 118 mL in 1 BOTTLE, PLASTIC 2017-04-30 0000-00-00 No No Current