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 43 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BLT 2	LIDOCAINE HCL	CENTURA PHARMACEUTICALS INC	41dc85ec-d79b-0a32-e054-00144ff8d46c	2026-01-12	Warnings	Exact identifier application number: M017
Mineral Ice Pain Relieving	MENTHOL	Crown Laboratories	7b30076a-0af6-2f74-e053-2a91aa0ae08d	2026-01-12	Warnings	Exact identifier application number: M017
Sarna	PRAMOXINE HYDROCHLORIDE	Crown Laboratories	19b0ce1b-e147-01a1-e063-6394a90af808	2026-01-12	Warnings	Exact identifier application number: M017
Sarna	PRAMOXINE HYDROCHLORIDE, MENTHOL	Crown Laboratories, Inc	19c41e75-a654-90cf-e063-6394a90a7e97	2026-01-12	Warnings	Exact identifier application number: M017
Itch Relief	DIPHENHYDRAMINE HCL, ZINC ACETATE	HY-VEE, INC	48350b54-8d9a-48c4-e063-6394a90ac040	2026-01-12	Warnings	Exact identifier application number: M017
LidoPlus Pain Relief	LIDOCAINE HYDROCHLORIDE	Centura Pharmaceuticals, Inc	07bacc6c-60a6-4297-8663-904a22bdc040	2026-01-12	Warnings	Exact identifier application number: M017
BlueStop Max	EXTERNAL ANALGESIC	Clavel Corporation	f1efb51c-5217-4cb2-e053-2a95a90a7f95	2026-01-12	Warnings	Exact identifier application number: M017
BlueStop Max	EXTERNAL ANALGESIC	Clavel Corporation	f2277e27-868b-57ef-e053-2a95a90abf28	2026-01-12	Warnings	Exact identifier application number: M017
BLT 3	TETRACAINE	CENTURA PHARMACEUTICALS INC	401a0d22-1181-02ac-e054-00144ff88e88	2026-01-12	Warnings	Exact identifier application number: M017
Sting Relief Prep Pad	BENZOCAINE	NINGBO TIANBO FIRST AID PRODUCT CO., LTD.	0c901f64-6890-45c0-9ca7-ee9de87903c4	2026-01-12	Warnings	Exact identifier application number: M017
Goodsense Oral Pain Relief	BENZOCAINE	Geiss, Destin and Dunn, Inc.	eb461b70-d10f-4e11-8374-e43713f3504d	2026-01-12	Warnings	Exact identifier application number: M017
Extra Strength Balm	CAPSICUM AND MENTHOL	Saje Natural Business Inc	f516e416-446b-8f21-e053-2a95a90afd88	2026-01-12	Warnings	Exact identifier application number: M017
Pain Release	MENTHOL	Saje Natural Business Inc.	3df0e56a-7651-42dc-8ed8-f68836a63c61	2026-01-12	Warnings	Exact identifier application number: M017
Trauma Less	MENTHOL	Saje Natural Business Inc.	650cba4c-6aba-48c3-9c41-841f19905548	2026-01-12	Warnings	Exact identifier application number: M017
Mamisan	LIDOCAINE HYDROCHLORIDE, MENTHOL	Miramar Cosmetics, Inc DBA Miramar Lab	4402e900-c6e9-4f32-8cc4-c84014384a9f	2026-01-12	Warnings	Exact identifier application number: M017
Curist Lidocaine Patch	LIDOCAINE 4% PATCH	Little Pharma, Inc.	1a8fe44e-7a21-c2ab-e063-6394a90a6100	2026-01-11	Warnings	Exact identifier application number: M017
DG Health Pain Relieving	LIDOCAINE HCL	DOLGENCORP, LLC	923aeb4c-049f-4ecc-a77e-9ffa0e236d4e	2026-01-11	Warnings	Exact identifier application number: M017
Campho-Phenique Antiseptic	CAMPHOR (SYNTHETIC) AND PHENOL	Foundation Consumer Healthcare	46b84e0b-78a9-4cde-9f90-e165b5419162	2026-01-09	Warnings	Exact identifier application number: M017
MyDerm Pro Freeze Cooling Menthol Pain Relief Roll-On	MENTHOL	Inspec Solutions	12ff9b9a-73e5-ce31-e063-6294a90aeaf8	2026-01-09	Warnings	Exact identifier application number: M017
Carmex Classic Lip Balm Medicated	CAMPHOR (SYNTHETIC), WHITE PETROLATUM	Carma Laboratories, Inc.	bb0278c9-eaff-d435-e053-2995a90a202a	2026-01-09	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