ActivICE

Product NDC: 53329-984
11-digit product format: 533290984
Labeler code: 53329
Product ID: 53329-984_5a6e9886-23df-e0ee-e063-6294a90a5e48
Type: HUMAN OTC DRUG
Nonproprietary name: menthol
Dosage form: GEL
Route: TOPICAL
Labeler: Medline Industries, LP
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-03-04
Substance: MENTHOL
Active strength: 80 mg/mL
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: ActivICE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	80 mg/mL

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
283257	Internal RxNorm lookup
2119857	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
834adeb9-38ad-0cfe-e053-2991aa0af82f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
111d457e-3138-4512-b0ba-d0cd760c4055	Product name	3	20250225
0426261e-1bb9-b78b-abd2-80da765a7e3e	Product name	2	20240513
7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7	Product name	5	20240320
0ac2f11f-f58d-baf2-71a0-680993b48a61	Product name	2	20231211
855d63c3-b090-4636-8fc7-6d39ad23c44f	Product name	1	20230829
bb58f410-04be-65dd-9211-e89ead899698	Product name	6	20230323
0fcbc38a-8b29-3348-1cef-5222ea53484f	Product name	4	20220516
c4e1eedc-aca2-4551-8382-89144ed9d049	Product name	3	20220126
8d368a34-1453-43ea-828d-0dbcd72b8794	Product name	8	20210622
d6bab9d2-edce-a213-4796-226ab15472c3	Product name	6	20200616
2487e6ef-d419-42fc-aaf8-7acc805d2370	Product name	2	20170718
e071c814-e5e7-e7ed-ec76-428765d9c66b	Product name	2	20151120
93148e06-b8d7-4e6c-853e-62f807d17fbb	Product name	1	20151014
dbb00be6-fb1c-4b0a-a770-31f7e05e247e	Product name	1	20150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53329-984-04	ActivICE	118 mL in 1 TUBE	GEL	118		11
53329-984-06	ActivICE	473 mL in 1 BOTTLE	GEL	473		11
53329-984-16	ActivICE	5.6 mL in 1 PACKET	GEL	5.6		11
53329-984-23	ActivICE	946 mL in 1 BOTTLE	GEL	946		11
53329-984-25	ActivICE	3785 mL in 1 BOTTLE	GEL	3785		11
53329-984-30	ActivICE	5.6 mL in 1 PACKET	GEL	5.6		11
53329-984-30	ActivICE	100 in 1 BOX	GEL	100		11
53329-984-16	Diclovix M	85 g in 1 PACKET	GEL	85 g	80 g in 1000g	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53329-984-16	ML - Milliliter	53329-984	6c576af8-8fb5-48c9-a559-ef13eb226fb1	1	2025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53329-984	ACTIVICE (MENTHOL) GEL [MEDLINE INDUSTRIES, LP]	10	Current NDC, Legacy NDC, 7 package rows	20241215_834adeb9-38ad-0cfe-e053-2991aa0af82f.zip
53329-984	DICLOVIX M (DICLOFENAC SODIUM, WITH CAMPHOR, LIDOCAINE, AND METHYL SALICYLATE PATCH) KIT [PRIMARY PHARMACEUTICALS, INC]	1	Current NDC, Legacy NDC	20200126_9d0012ed-a50a-a936-e053-2995a90a6100.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 107 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
pain relief roll-on	LIDOCAINE 4%	Bionpharma Inc.	f607b6dc-8d13-604a-e053-2995a90a59ab	2024-12-23	Warnings	Exact identifier application number: M017
Veneno de Abeja Aceite De Vibora Brand	METHYL SALICYLATE	Miramar Cosmetics, Inc DBA Miramar Lab	a6c4889c-e7a9-44b9-bd9a-70fd6e8c4825	2024-12-23	Warnings	Exact identifier application number: M017
Itch Relief	HYDROCORTISONE 1%	Trifecta Pharmaceuticals USA LLC	af5daf6c-bcad-8ebf-e053-2a95a90af1b0	2024-12-20	Warnings	Exact identifier application number: M017
Pain Itch Relief	LIDOCAINE HCI	Trifecta Pharmaceutical USA LLC	f40b19a8-795c-f514-e053-2a95a90a6d15	2024-12-20	Warnings	Exact identifier application number: M017
Muscle Rub Cream	MENTHOL 10%, METHYL SALICYLATE 15%	Trifecta Pharmaceuticals USA, LLC.	44d3638d-f29b-0e01-e054-00144ff88e88	2024-12-20	Warnings	Exact identifier application number: M017
Rhuli Gel	CAMPHOR, MENTHOL	Trifecta Pharmaceuticals USA, LLC.	4fbb3c23-ed47-336e-e054-00144ff8d46c	2024-12-20	Warnings	Exact identifier application number: M017
Hydrocortisone Cream with Aloe	HYDROCORTISONE	Rugby Laboratories	132982ea-cce6-687c-e063-6294a90a4632	2024-12-20	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE 1%	Pharmacy Value Alliance LLC	9bb98452-a605-5c20-e053-2995a90a1ea7	2024-12-20	Warnings	Exact identifier application number: M017
DCH Cooling Pain Relief	MENTHOL 10.5%	Derma Care Research Labs, LLC	00dcdae0-c744-8402-e063-6294a90a12f8	2024-12-20	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE 1%	Pharmacy Value Alliance LLC	ab95e606-69f0-1d58-e053-2a95a90a073b	2024-12-20	Warnings	Exact identifier application number: M017
Itch Relief Cream	ZINC ACETATE 0.1%, DIPHENHYDRAMINE HYDROCHLORIDE 2%	Pharmacy Value Alliance LLC	37fe6d82-adee-4f58-e054-00144ff88e88	2024-12-20	Warnings	Exact identifier application number: M017
Warrior First Aid Anti Itch	DIPHENHYDRAMINE HCL 2%, ZINC ACETATE 0.1%	Derma Care Research Labs, LLC	ec6e9a5b-c61d-a385-e053-2995a90ac936	2024-12-20	Warnings	Exact identifier application number: M017
DCH Burn Relief	LIDOCAINE HCL	Derma Care Research Labs, LLC	ff227154-cf3b-9796-e053-6294a90a5535	2024-12-20	Warnings	Exact identifier application number: M017
Outback Pain Relief	CAMPHOR 6%, MENTHOL 16%	Derma Care Research Labs, LLC	c238c930-2012-2d48-e053-2a95a90a8a4a	2024-12-20	Warnings	Exact identifier application number: M017
Meijer Pain Relief	LIDOCAINE HCL 4%	Meijer	f31b11ed-2ff9-5cfc-e053-2a95a90af2ca	2024-12-20	Warnings	Exact identifier application number: M017
Meijer Pain Relief	MENTHOL 10.5%	Meijer	bed81975-bd63-cf5b-e053-2995a90ac5fa	2024-12-20	Warnings	Exact identifier application number: M017
Mirakel Pain and Itch Relief	BENZOCAINE 20%, RESORCINOL 3%	Sanvio, Inc.	ed34d728-0275-e209-e053-2995a90a93ff	2024-12-20	Warnings	Exact identifier application number: M017
Meijer Pain Relief	LIDOCAINE 4%	Meijer	bed67c31-c479-6f9b-e053-2a95a90a5516	2024-12-20	Warnings	Exact identifier application number: M017
Blue-Emu Ultra with Hemp Seed	TROLAMINE SALICYLATE	Kingsway Pharmaceuticals dba NFI, LLC	80a3cf99-16e8-412b-ab9f-3d9d5cbb7aa9	2024-12-20	Warnings	Exact identifier application number: M017
Epsom Salts	MAGNESIUM SULFATE	International Wholesale Inc.	e4d9bc32-ac85-349f-e053-2995a90a032f	2024-12-19	Warnings	Exact identifier application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2119857	ActivICE 8 % Topical Gel	PSN	834adeb9-38ad-0cfe-e053-2991aa0af82f	11
283257	menthol 8 % Topical Gel	PSN	834adeb9-38ad-0cfe-e053-2991aa0af82f	11
2119857	menthol 0.08 MG/MG Topical Gel [ActivICE]	SBD	834adeb9-38ad-0cfe-e053-2991aa0af82f	11
283257	menthol 0.08 MG/MG Topical Gel	SCD	834adeb9-38ad-0cfe-e053-2991aa0af82f	11
2119857	ActivICE 0.08 MG/MG Topical Gel	SY	834adeb9-38ad-0cfe-e053-2991aa0af82f	11
283257	menthol 8 % Topical Gel	SY	834adeb9-38ad-0cfe-e053-2991aa0af82f	11
2119857	ActivICE 8 % Topical Gel	PSN	9d0012ed-a50a-a936-e053-2995a90a6100	1
857700	diclofenac sodium 1.5 % Topical Solution	PSN	9d0012ed-a50a-a936-e053-2995a90a6100	1
283257	menthol 8 % Topical Gel	PSN	9d0012ed-a50a-a936-e053-2995a90a6100	1
2119857	menthol 0.08 MG/MG Topical Gel [ActivICE]	SBD	9d0012ed-a50a-a936-e053-2995a90a6100	1
857700	diclofenac sodium 15 MG/ML Topical Solution	SCD	9d0012ed-a50a-a936-e053-2995a90a6100	1
283257	menthol 0.08 MG/MG Topical Gel	SCD	9d0012ed-a50a-a936-e053-2995a90a6100	1
2119857	ActivICE 0.08 MG/MG Topical Gel	SY	9d0012ed-a50a-a936-e053-2995a90a6100	1
857700	diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical Solution	SY	9d0012ed-a50a-a936-e053-2995a90a6100	1
857700	diclofenac sodium 16.05 MG per 1 ML Topical Solution	SY	9d0012ed-a50a-a936-e053-2995a90a6100	1
283257	menthol 8 % Topical Gel	SY	9d0012ed-a50a-a936-e053-2995a90a6100	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53329-984-04	53329098404	118 mL in 1 TUBE (53329-984-04)	118 ml	2019-03-04	0000-00-00	No	No	Current
53329-984-06	53329098406	473 mL in 1 BOTTLE (53329-984-06)	473 ml	2019-03-04	0000-00-00	No	No	Current
53329-984-16	53329098416	5.6 mL in 1 PACKET (53329-984-16)	5.6 ml	2019-03-04	0000-00-00	No	No	Current
53329-984-23	53329098423	946 mL in 1 BOTTLE (53329-984-23)	946 ml	2019-03-04	0000-00-00	No	No	Current
53329-984-25	53329098425	3785 mL in 1 BOTTLE (53329-984-25)	3785 ml	2019-03-04	0000-00-00	No	No	Current
53329-984-30	53329098430	100 PACKET in 1 BOX (53329-984-30) / 5.6 mL in 1 PACKET	100 packet	2019-03-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
984 ActivIce gel	Medline Industries, LP	2026-09-01	HUMAN OTC DRUG LABEL	12
diclofenac sodium, with capsaicin cream and menthol gel	Primary Pharmaceuticals, Inc \| Rainbow Gold	2021-02-08	HUMAN PRESCRIPTION DRUG LABEL	2
diclofenac sodium, with camphor, lidocaine, and methyl salicylate patch	Primary Pharmaceuticals, Inc \| Rainbow Gold	2020-01-25	HUMAN PRESCRIPTION DRUG LABEL	1