Avedana Cool Hot Ice

Product NDC: 43749-321
11-digit product format: 437490321
Labeler code: 43749
Product ID: 43749-321_1850af06-be68-45cd-a107-604506bef374
Type: HUMAN OTC DRUG
Nonproprietary name: Menthol
Dosage form: GEL
Route: TOPICAL
Labeler: Unipack, Inc.
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2017-11-04
Substance: MENTHOL
Active strength: 2 g/100g
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: Avedana Cool Hot Ice
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	2 g/100g

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
311502	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
619c8e3f-0cad-4eb1-8dbb-632f3db74ba3	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43749-321-08	Avedana Cool Hot Ice	227 g in 1 JAR	GEL	227		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43749-321	AVEDANA COOL HOT ICE (MENTHOL) GEL [UNIPACK, INC.]	2	Current NDC, Legacy NDC, 1 package rows	20180502_619c8e3f-0cad-4eb1-8dbb-632f3db74ba3.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
Avedana Cool Hot Ice	MENTHOL	Unipack, Inc.	619c8e3f-0cad-4eb1-8dbb-632f3db74ba3	2018-05-01	Warnings	Exact identifier ndc (product): 43749-321

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
311502	menthol 2 % Topical Gel	PSN	619c8e3f-0cad-4eb1-8dbb-632f3db74ba3	2
311502	menthol 0.02 MG/MG Topical Gel	SCD	619c8e3f-0cad-4eb1-8dbb-632f3db74ba3	2
311502	menthol 2 % Topical Gel	SY	619c8e3f-0cad-4eb1-8dbb-632f3db74ba3	2
311502	menthol 2 % topical stick	SY	619c8e3f-0cad-4eb1-8dbb-632f3db74ba3	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43749-321-08	43749032108	227 g in 1 JAR (43749-321-08)	227 g	2017-11-04	0000-00-00	No	No	Current