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 137 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Burn First Aid	BURN FIRST AID	Dynarex Corporation	826e08be-dffa-5a27-e053-2a91aa0a8701	2024-01-22	Warnings	Exact identifier application number: M017
Target Up and Up Pain Relief Menthol Topical Analgesic Roll-On	MENTHOL	TARGET CORPORATION	0f95fc55-8665-9e89-e063-6394a90a7891	2024-01-22	Warnings	Exact identifier application number: M017
CVS Health Lidocaine Pain Relief Plus Menthol	LIDOCAINE, MENTHOL, UNSPECIFIED FORM	Natural Essentials, Inc.	77978069-a1b4-473e-83c9-8320e00eea89	2024-01-19	Warnings	Exact identifier application number: M017
ZIMS MAX FREEZE LEG CRAMPS	CAMPHOR, MENTHOL	KOBAYASHI Healthcare International, Inc.	ba26635d-95d3-4d88-93cc-1fd4fd29fd79	2024-01-18	Warnings	Exact identifier application number: M017
Burn	LIDOCAINE	HART Health	e95ebdac-9789-41c2-97da-2307e4538794	2024-01-18	Warnings	Exact identifier application number: M017
Medi-First Hydrocortisone 1%	HYDROCORTISONE ACETATE	Unifirst First Aid Corporation	bd216f5d-f304-7d8d-e053-2a95a90aa9ce	2024-01-17	Warnings	Exact identifier application number: M017
Green Guard Hydrocortisone 1%	HYDROCORTISONE	Unifirst First Aid Corporation	bd348e2a-57b1-3f17-e053-2a95a90a8bdc	2024-01-17	Warnings	Exact identifier application number: M017
Pain Relief	LIDOCAINE, MENTHOL	HUMN Pharmaceuticals Inc	6c96f94a-e724-eab3-e053-2991aa0aab88	2024-01-17	Warnings	Exact identifier application number: M017
CVS Health Lidocaine Pain Relief	LIDOCAINE	Natural Essentials, Inc.	52e82e70-53b7-4ecb-be39-fe10c94cc444	2024-01-17	Warnings	Exact identifier application number: M017
CVS Health XL Lidocaine Pain Relief	LIDOCAINE	NATURAL ESSENTIALS, INC.	ec16da91-8244-402b-b8d8-84896094ac2c	2024-01-17	Warnings	Exact identifier application number: M017
Anti-itch	DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE	Target Corporation	f444b0a6-2ed3-4236-8206-342150290675	2024-01-17	Warnings	Exact identifier application number: M017
Maximum Strength Hydrocortisone Anti-itch	HYDROCORTISONE 1%	Target Corporation	4ff39cb8-3a20-4fe7-9829-1e882a484668	2024-01-17	Warnings	Exact identifier application number: M017
Burn	LIDOCAINE HYDROCHLORIDE	Nantong Health & Beyond Hygienic Products Inc.	eca272cb-ac8f-982b-e053-2995a90aa8b2	2024-01-15	Warnings	Exact identifier application number: M017
American Safety and First Aid	HYDROCORTISONE ACETATE	Orazen Inc	eb0cfde0-c463-e9b5-e053-2a95a90a1924	2024-01-15	Warnings	Exact identifier application number: M017
American Safety and First Aid	HYDROCORTISONE ACETATE	Orazen Inc	eb0cce4b-c70a-1b2d-e053-2995a90aa4aa	2024-01-15	Warnings	Exact identifier application number: M017
Oral Pain Relief Gel	BENZOCAINE 20%	Sled Distribution, LLC	e7391302-831e-14dc-e053-2a95a90ac236	2024-01-15	Warnings	Exact identifier application number: M017
FIRST SHIELD	LIDOCAINE HCI	Ever Ready First Aid	e022bf8f-3dd8-de22-e053-2995a90a219b	2024-01-15	Warnings	Exact identifier application number: M017
Flexigen	MENTHOL 1.25%	Derma Care Research Labs, LLC	e9ae2682-59b4-e796-e053-2995a90af921	2024-01-15	Warnings	Exact identifier application number: M017
Vita-P Oral and Nasal	MENTHOL 1%	Beijing HKKY Medical Tech. Co., Ltd.	537c3843-1c92-41c6-b724-52701bbddeab	2024-01-13	Warnings	Exact identifier application number: M017
Caring mill Lidocaine Aloe Gel Burn and Pain Relief	LIDOCAINE HYDROCHLORIDE	FSA Store Inc.	0ec20c87-1681-dd23-e063-6394a90a291c	2024-01-12	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