Home NDC 61010-1550 Pain Relieving Roll-On
Product NDC 61010-1550
11-digit product format 610101550
Labeler code 61010
Product ID 61010-1550_10a91ff8-4d59-15dd-e063-6394a90a3aad
Type HUMAN OTC DRUG
Nonproprietary name menthol, unspecified form
Dosage form GEL
Route TOPICAL
Labeler Safetec of America, Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-10-07
Substance MENTHOL, UNSPECIFIED FORM
Active strength 7 g/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 Pain Relieving Roll-On
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL, UNSPECIFIED FORM 7 g/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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311509 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61010-1550-1 Pain Relieving Roll-On 88 mL in 1 BOTTLE GEL 88 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61010-1550 PAIN RELIEVING ROLL-ON (MENTHOL, UNSPECIFIED FORM) GEL [SAFETEC OF AMERICA, INC.] 2 Current NDC, Legacy NDC, 1 package rows 20240214_80118260-9c88-402d-9a90-ecfe62b4b54f.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 76 of 151 · 3,010 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 61010-1550-1 61010155001 88 mL in 1 BOTTLE (61010-1550-1) 88 ml 2019-10-07 0000-00-00 No No Current