Analgesic

Product NDC: 61010-8202
11-digit product format: 610108202
Labeler code: 61010
Product ID: 61010-8202_a4cdd5eb-fbda-4f99-b737-452a1487adfd
Type: HUMAN OTC DRUG
Nonproprietary name: menthol
Dosage form: GEL
Route: TOPICAL
Labeler: Safetec of America, Inc.
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2018-09-01
Substance: MENTHOL
Active strength: 70 mg/L
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: Analgesic
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	70 mg/L

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
a90266d4-1e71-4805-aeca-6f8ed45135bb	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61010-8202-0	Analgesic	0.088 L in 1 BOTTLE, WITH APPLICATOR	GEL	0.088		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61010-8202	ANALGESIC (MENTHOL) GEL [SAFETEC OF AMERICA, INC.]	1	Current NDC, Legacy NDC, 1 package rows	20180906_a90266d4-1e71-4805-aeca-6f8ed45135bb.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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Analgesic	MENTHOL	Safetec of America, Inc.	a90266d4-1e71-4805-aeca-6f8ed45135bb	2018-10-01	Warnings	Exact identifier ndc (product): 61010-8202

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
61010-8202-0	61010820200	.088 L in 1 BOTTLE, WITH APPLICATOR (61010-8202-0)	2018-09-01	0000-00-00	No	No	Current