Home NDC 69452-375 cool and heat pain relieving liquid
Product NDC 69452-375
11-digit product format 694520375
Labeler code 69452
Product ID 69452-375_29f91a1d-7cce-3cab-e063-6394a90a0274
Type HUMAN OTC DRUG
Nonproprietary name Menthol
Dosage form LIQUID
Route TOPICAL
Labeler Bionpharma Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-11-01
Substance MENTHOL
Active strength 16 mg/100mL
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 cool and heat pain relieving liquid
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 16 mg/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L7T10EIP3A Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69452-375-96 cool and heat pain relieving liquid 1 in 1 CARTON LIQUID 1 2 69452-375-96 cool and heat pain relieving liquid 74 mL in 1 CONTAINER LIQUID 74 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69452-375 COOL AND HEAT PAIN RELIEVING LIQUID (MENTHOL) LIQUID [BIONPHARMA INC.] 2 Current NDC, Legacy NDC, 2 package rows 20241225_ec6f59d8-45c5-46a0-e053-2995a90a239f.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 109 of 153 · 3,057 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69452-375-96 69452037596 1 CONTAINER in 1 CARTON (69452-375-96) / 74 mL in 1 CONTAINER 1 container 2022-11-01 0000-00-00 No No Current