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 108 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Epsom Salts	MAGNESIUM SULFATE	International Wholesale Inc.	e5f3edc2-1b79-533a-e053-2a95a90ae9b6	2024-12-19	Warnings	Exact identifier application number: M017
Leader	LIDOCAINE HCL	Cardinal Health	cea6bd2d-a265-1209-e053-2995a90ab0a5	2024-12-19	Warnings	Exact identifier application number: M017
Rugby Anti-Itch	CAMPHOR, MENTHOL	RUGBY LABORATORIES	99d8ad9e-46ec-15fc-e053-2995a90a0d17	2024-12-19	Warnings	Exact identifier application number: M017
DCH Calaspray Itch Relief	PRAMOXINE HCL 1%, ZINC ACETATE 0.1%	Derma Care Research Labs, LLC	fda2afaf-3cd0-92b3-e053-6394a90a7493	2024-12-19	Warnings	Exact identifier application number: M017
DCH Nerve Pain Relief Roll-On	LIDOCAINE HCL 4%, MENTHOL 1%	Derma Care Research Labs, LLC	ff32cbb2-79eb-9158-e053-6394a90ac357	2024-12-19	Warnings	Exact identifier application number: M017
DCH Burn Relief	LIDOCAINE, 0.5%	Derma Care Research Labs	ffd7be08-0510-dfcb-e053-6394a90ad286	2024-12-19	Warnings	Exact identifier application number: M017
DCH Arthritis Pain Relief Roll-On	CAPSAISIN 0.1%	Derma Care Research Labs, LLC	fda0d359-95eb-8b38-e053-6294a90a7b88	2024-12-19	Warnings	Exact identifier application number: M017
DCH Pain Relieving	MENTHOL 2%	Derma Care Research Labs, LLC	ff49ee63-6a87-c7a7-e053-6294a90a77a3	2024-12-19	Warnings	Exact identifier application number: M017
Warrior Pain Relief Roll-On Maximum Strength	LIDOCAINE HCL 4%	Derma Care Research Labs, LLC	dd80e560-6467-2166-e053-2995a90a88a8	2024-12-19	Warnings	Exact identifier application number: M017
DCH Labs Cool and Heat Roll-On	MENTHOL 16%	Derma Care Research Labs, LLC	d35d7720-44ce-3624-e053-2995a90a7fb4	2024-12-19	Warnings	Exact identifier application number: M017
Dr Goldsons Pain	MENTHOL 8%, METHYL SALICYLATE 30%	Derma Care Research Labs, LLC	fb34b0d3-ccc0-305e-e053-6394a90a231d	2024-12-19	Warnings	Exact identifier application number: M017
Warrior Pain Relieving	CAMPHOR 4%, MENTHOL 10%, METHYL SALICYLATE 30%	Derma Care Research Labs, LLC	dd06af3c-5452-9759-e053-2a95a90afc21	2024-12-19	Warnings	Exact identifier application number: M017
Warrior Burn Relief Aloe Maximum Strength	LIDOCAINE HCL 4%	Derma Care Research Labs, LLC	ec6efa4b-dcbe-1c2b-e053-2995a90ae043	2024-12-19	Warnings	Exact identifier application number: M017
DCH Arthritis Relief	TROLAMIN SALICYLATE 10%	Derma Care Research Labs, LLC	ff31e515-5780-b77d-e053-6394a90af6b9	2024-12-19	Warnings	Exact identifier application number: M017
DCH Pain Relief	LIDOCAINE 4%	Derma Care Research Labs, LLC	00efda74-d434-04be-e063-6294a90a6d98	2024-12-19	Warnings	Exact identifier application number: M017
Dollar General Cold Therapy Pain Relief	MENTHOL 5%	Dolgencorp, LLC	ff3284d1-e73c-93bf-e053-6294a90aaf4e	2024-12-19	Warnings	Exact identifier application number: M017
Dollar General Pain Relieving Patch with Lidocaine	LIDOCAINE	DOLGENCORP, LLC	55828cd1-3a1e-48ac-bb01-4c50b96d09a2	2024-12-19	Warnings	Exact identifier application number: M017
DCH Nerve Pain Relief	LIDOCAINE 4%, MENTHOL 1%	Derma Care Research Labs, LLC	00db480a-e510-a64d-e063-6394a90a4695	2024-12-19	Warnings	Exact identifier application number: M017
Pain, Burn, and Itch Relief	BENZOCAINE 20%, MENTHOL 0.5%	Derma Care Research Labs, LLC	fd9fe09f-3ae9-c5f5-e053-6394a90ad691	2024-12-19	Warnings	Exact identifier application number: M017
DCH Cooling Pain Relief	MENTHOL 4%	Derma Care Research Labs, LLC	00ed3175-c3ba-6545-e063-6394a90acfd1	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