ActivICE

Product NDC: 53329-991
11-digit product format: 533290991
Labeler code: 53329
Product ID: 53329-991_26bebd7d-b1e7-5e7e-e063-6394a90a273a
Type: HUMAN OTC DRUG
Nonproprietary name: menthol
Dosage form: SPRAY
Route: TOPICAL
Labeler: Medline Industries, LP
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-03-04
Substance: MENTHOL
Active strength: 80 g/1000g
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: ActivICE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	80 g/1000g

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
351286	Internal RxNorm lookup
2119854	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
8414aea2-52b5-4221-e053-2a91aa0a622e	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53329-991-04	ActivICE	113.4 g in 1 BOTTLE, SPRAY	SPRAY	113.4		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53329-991	ACTIVICE (MENTHOL) SPRAY [MEDLINE INDUSTRIES, LP]	6	Current NDC, Legacy NDC, 1 package rows	20241215_8414aea2-52b5-4221-e053-2a91aa0a622e.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 141 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rite Aid Anti-itch	HYDROCORTISONE	Rite Aid	0c540422-1579-9217-e063-6294a90ad06a	2023-12-12	Warnings	Exact identifier application number: M017
Anti-itch Paraben Free	HYDROCORTISONE	Weeks & Leo Co., Inc.	0c5419c5-0929-7ca6-e063-6294a90ac0a7	2023-12-12	Warnings	Exact identifier application number: M017
Rite Aid Hydrocortisone	HYDROCORTISONE 1%	Rite Aid	0c580f96-7fe9-19df-e063-6394a90a5a22	2023-12-12	Warnings	Exact identifier application number: M017
Anti itch	HYDROCORTISONE	Weeks & Leo Co., Inc.	0c58b750-d3a6-5ed1-e063-6294a90a4321	2023-12-12	Warnings	Exact identifier application number: M017
Greencaine Blast	LIDOCAINE	ALMA Laboratories, Inc.	031e0065-4c8a-43d8-bc69-3efa3c6c0ae3	2023-12-12	Warnings	Exact identifier application number: M017
Ageless Pain Relief	METHYL SALICYLATE, MENTHOL	Isagenix International, LLC	3c7e493b-923d-44b1-9076-46c7894308d4	2023-12-12	Warnings, Adverse reactions	Exact identifier application number: M017
CVS Extra Strength Itch Stopping	DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE	CVS	857af609-9dd7-a07a-e053-2991aa0ab6ba	2023-12-11	Warnings	Exact identifier application number: M017
Rite Aid Extra Strength Itch Stopping	DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE	Rite Aid	0c4170dd-e1fa-d549-e063-6394a90a5c23	2023-12-11	Warnings	Exact identifier application number: M017
Westlake Itch Relief	DIPHENHYDRAMINE HCL, ZINC ACETATE	Westlake HB Pharma LLC	0c416ba6-b01f-0609-e063-6294a90ae2a1	2023-12-11	Warnings	Exact identifier application number: M017
CVS Regular Strength Itch Stopping	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	CVS	87473ace-d834-e43f-e053-2a95a90a819c	2023-12-11	Warnings	Exact identifier application number: M017
Katinko External Analgesic Oil	CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE	Greenstone Pharmaceutical Inc.	5881fc35-3293-4f0b-801a-afcd6feb9496	2023-12-08	Warnings	Exact identifier application number: M017
Katinko Pain And Itch Relieving	CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE	Greenstone Pharmaceutical Inc.	fe907fa4-4a01-4974-b71f-9cd980b4eaa2	2023-12-08	Warnings, Adverse reactions	Exact identifier application number: M017
Cycle	MENTHOL	La Mend, Inc.	cfc0bcde-ef91-1e6c-e053-2a95a90ab79e	2023-12-07	Warnings	Exact identifier application number: M017
Hemorrhoidal Pain Relief Cream	GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM	WALGREENS	03bbe146-f185-bcfa-e063-6394a90a85bf	2023-12-04	Warnings	Exact identifier application number: M017
Quatriderm Anti-itch	HYDROCORTISONE	OPMX LLC	83e59e10-9878-e5c2-e053-2a91aa0af25e	2023-12-04	Warnings	Exact identifier application number: M017
TACT	DIPHENHYDRAMINE HYDROCHLORIDE, MENTHOL	Sato Pharmaceutical Inc., Ltd.	b6e2ee24-69de-4dfd-9081-b9537b7a7bad	2023-12-04	Warnings	Exact identifier application number: M017
Overnight Cold Therapy Pain Relief	MENTHOL, UNSPECIFIED FORM	Walgreen Co.	2cbd0966-4cf9-4271-bd53-6672b1ed2a99	2023-12-04	Warnings	Exact identifier application number: M017
Prolayed Lidocaine Male Genital Desensitizer	LIDOCAINE	ViaDerma Distribution, Inc.	9c5ad0d0-ca7a-4321-9334-f06f3f6be18f	2023-12-02	Warnings	Exact identifier application number: M017
Liberdol Topical Analgesic	METHYL SALICYLATE, MENTHOL, CAMPHOR (SYNTHETIC)	ViaDerma Distribution, Inc	ab52cd0e-34fa-41c7-9ce7-1183c2aff8d8	2023-12-01	Warnings	Exact identifier application number: M017
Prolayed	LIDOCAINE	MATRIX MIXOLOGY, INC	ae317876-adb1-6d13-e053-2995a90a74af	2023-12-01	Warnings	Exact identifier application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2119854	ActivICE 8 % Topical Spray	PSN	8414aea2-52b5-4221-e053-2a91aa0a622e	6
351286	menthol 8 % Topical Spray	PSN	8414aea2-52b5-4221-e053-2a91aa0a622e	6
2119854	menthol 80 MG/ML Topical Spray [ActivICE]	SBD	8414aea2-52b5-4221-e053-2a91aa0a622e	6
351286	menthol 80 MG/ML Topical Spray	SCD	8414aea2-52b5-4221-e053-2a91aa0a622e	6
2119854	ActivICE 80 MG/ML Topical Spray	SY	8414aea2-52b5-4221-e053-2a91aa0a622e	6
351286	menthol 8 % Topical Spray	SY	8414aea2-52b5-4221-e053-2a91aa0a622e	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53329-991-04	53329099104	113.4 g in 1 BOTTLE, SPRAY (53329-991-04)	113.4 g	2019-03-04	0000-00-00	No	No	Current