FDA.reportPublic FDA data

ActivICE

Product NDC
53329-984
11-digit product format
533290984
Labeler code
53329
Product ID
53329-984_41d6f934-693e-24d3-e063-6294a90a2026
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

Additional Listing Data#

Finished product
Yes
Brand name base
ActivICE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL80 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
283257Internal RxNorm lookup
2119857Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
834adeb9-38ad-0cfe-e053-2991aa0af82fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
111d457e-3138-4512-b0ba-d0cd760c4055Product name320250225
0426261e-1bb9-b78b-abd2-80da765a7e3eProduct name220240513
7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7Product name520240320
0ac2f11f-f58d-baf2-71a0-680993b48a61Product name220231211
855d63c3-b090-4636-8fc7-6d39ad23c44fProduct name120230829
bb58f410-04be-65dd-9211-e89ead899698Product name620230323
0fcbc38a-8b29-3348-1cef-5222ea53484fProduct name420220516
c4e1eedc-aca2-4551-8382-89144ed9d049Product name320220126
8d368a34-1453-43ea-828d-0dbcd72b8794Product name820210622
d6bab9d2-edce-a213-4796-226ab15472c3Product name620200616
2487e6ef-d419-42fc-aaf8-7acc805d2370Product name220170718
e071c814-e5e7-e7ed-ec76-428765d9c66bProduct name220151120
93148e06-b8d7-4e6c-853e-62f807d17fbbProduct name120151014
dbb00be6-fb1c-4b0a-a770-31f7e05e247eProduct name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-984-04ActivICE118 mL in 1 TUBEGEL11811
53329-984-06ActivICE473 mL in 1 BOTTLEGEL47311
53329-984-16ActivICE5.6 mL in 1 PACKETGEL5.611
53329-984-23ActivICE946 mL in 1 BOTTLEGEL94611
53329-984-25ActivICE3785 mL in 1 BOTTLEGEL378511
53329-984-30ActivICE5.6 mL in 1 PACKETGEL5.611
53329-984-30ActivICE100 in 1 BOXGEL10011
53329-984-16Diclovix M85 g in 1 PACKETGEL85 g80 g in 1000g1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53329-984-16ML - Milliliter53329-9846c576af8-8fb5-48c9-a559-ef13eb226fb112025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-984ACTIVICE (MENTHOL) GEL [MEDLINE INDUSTRIES, LP]10Current NDC, Legacy NDC, 7 package rows20241215_834adeb9-38ad-0cfe-e053-2991aa0af82f.zip
53329-984DICLOVIX M (DICLOFENAC SODIUM, WITH CAMPHOR, LIDOCAINE, AND METHYL SALICYLATE PATCH) KIT [PRIMARY PHARMACEUTICALS, INC]1Current NDC, Legacy NDC20200126_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 1 of 153 · 3,056 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Icy Hot Original Nighttime Recovery Pain Relief No Mess Roll OnMENTHOLChattem, Inc.aa40c907-eeb5-4fda-b35e-439cbecc178c2026-07-31WarningsExact identifier
application number: M017
Aspercreme with Lidocaine DryLIDOCAINEChattem, Inc.008abaaa-5e12-4246-a7f5-66f3966acf282026-07-30WarningsExact identifier
application number: M017
Icy Hot Performance No-Mess Pain Relief CreamMENTHOL 16%, CAMPHOR 11%Chattem, Inc.5e3e272a-c001-4f57-9535-521ccc85ae652026-07-30WarningsExact identifier
application number: M017
Auixudin Lidocaine Pain Relief Gel-PatchLIDOCAINE PAIN RELIEF GEL-PATCHHenan Enokon Medical Instrument Co., Ltd.57bc7b9e-e2f7-724b-e063-6394a90ab36f2026-07-29WarningsExact identifier
application number: M017
Jinfahe Lidocaine Pain Relief PatchLIDOCAINE PAIN RELIEF PATCHHenan Enokon Medical Instrument Co., Ltd.57bcd9c5-767e-b634-e063-6394a90a28782026-07-29WarningsExact identifier
application number: M017
Maximun Strength Lidocaine Patch Plus MentholLIDOCAINE, MENTHOLMeijer Distribution Incd0468514-58ea-4d8f-b634-a65bf95c03162026-07-29WarningsExact identifier
application number: M017
Oudetas Lidocaine CreamLIDOCAINE CREAMGuangzhou Jingliang Cosmetics Co., Ltd.57ca9220-2778-790a-e063-6294a90af5062026-07-29WarningsExact identifier
application number: M017
Aspercreme Lidocaine No-Mess plus LavenderLIDOCAINE HCLChattem, Inc.3948a3d2-ce04-4703-8709-211e75c9c38d2026-07-29WarningsExact identifier
application number: M017
LidoProLIDOCAINE AND MENTHOLClinic Pharmacdfd6b39-b430-4e95-a0f7-682cf3d78b522026-07-28WarningsExact identifier
application number: M017
LidoPro Patch (Lidocaine 4%, Menthol 1%)LIDOCAINE AND MENTHOL PATCHClinic Pharma2b4d2105-b7ad-2695-e063-6394a90a999b2026-07-28WarningsExact identifier
application number: M017
Earths Care Pain RelievingCAMPHOR, MENTHOL, METHYL SALICYLATEDLC Laboratories, Inc.5c3976da-a6cb-4b94-ae41-3e86b1ab13cb2026-07-28WarningsExact identifier
application number: M017
Muscle Rub CreamMENTHOL 10%, METHYL SALICYLATE 15%Preferred Pharmaceuticals Inc.9e7568b6-52ae-4f7a-9bfd-503fd80a297e2026-07-28WarningsExact identifier
application number: M017
Aspercreme Lidocaine with Rosemary and MintLIDOCAINE HYDROCHLORIDEChattem, Inc.9d40bfea-85d0-4943-83e9-0c16e79a011c2026-07-28WarningsExact identifier
application number: M017
KENS PAIN AND ARTHRITIS FORMULAMENTHOLEezaway Relief Inc35834473-3ad5-41ec-a110-e742aa7e2ee42026-07-28WarningsExact identifier
application number: M017
DERMFREE Lidocaine 4% NUMBING Topical Anorectal CreamLIDOCAINE 4% NUMBING TOPICAL ANORECTAL CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.57935b64-6e2e-85d0-e063-6394a90a74282026-07-27WarningsExact identifier
application number: M017
1% Hydrocortisone Anti-itch1% HYDROCORTISONE ANTI-ITCHALAINA HEALTHCARE PRIVATE LIMITEDb8416467-55f7-4e5f-a5cb-3abd3e2bb5772026-07-27WarningsExact identifier
application number: M017
OWELL NATURALS ARTHRITIS MAXIMUM STRENGTHMENTHOLOWELL NATURAL 8 LLC57984bc2-bf1d-c423-e063-6394a90a06ae2026-07-27WarningsExact identifier
application number: M017
Original Pain ReliefTOPICAL ANALGESIC LOTIONReal Time Pain Relief Inc579bd303-9a50-4d66-e063-6294a90a61412026-07-27WarningsExact identifier
application number: M017
Lidfix Pain Relief Patch LidocaineLIDOCAINEHETERO HEALTHCARE LIMITED2149f0e3-1983-4f02-929e-ecd20357f4bb2026-07-27WarningsExact identifier
application number: M017
RectoProtectLIDOCAINEAkron Pharma Inc.1ca7d6cf-85a1-41a6-a07f-cff06a7edfbb2026-07-27WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2119857ActivICE 8 % Topical GelPSN834adeb9-38ad-0cfe-e053-2991aa0af82f11
283257menthol 8 % Topical GelPSN834adeb9-38ad-0cfe-e053-2991aa0af82f11
2119857menthol 0.08 MG/MG Topical Gel [ActivICE]SBD834adeb9-38ad-0cfe-e053-2991aa0af82f11
283257menthol 0.08 MG/MG Topical GelSCD834adeb9-38ad-0cfe-e053-2991aa0af82f11
2119857ActivICE 0.08 MG/MG Topical GelSY834adeb9-38ad-0cfe-e053-2991aa0af82f11
283257menthol 8 % Topical GelSY834adeb9-38ad-0cfe-e053-2991aa0af82f11
2119857ActivICE 8 % Topical GelPSN9d0012ed-a50a-a936-e053-2995a90a61001
857700diclofenac sodium 1.5 % Topical SolutionPSN9d0012ed-a50a-a936-e053-2995a90a61001
283257menthol 8 % Topical GelPSN9d0012ed-a50a-a936-e053-2995a90a61001
2119857menthol 0.08 MG/MG Topical Gel [ActivICE]SBD9d0012ed-a50a-a936-e053-2995a90a61001
857700diclofenac sodium 15 MG/ML Topical SolutionSCD9d0012ed-a50a-a936-e053-2995a90a61001
283257menthol 0.08 MG/MG Topical GelSCD9d0012ed-a50a-a936-e053-2995a90a61001
2119857ActivICE 0.08 MG/MG Topical GelSY9d0012ed-a50a-a936-e053-2995a90a61001
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSY9d0012ed-a50a-a936-e053-2995a90a61001
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSY9d0012ed-a50a-a936-e053-2995a90a61001
283257menthol 8 % Topical GelSY9d0012ed-a50a-a936-e053-2995a90a61001

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53329-984-0453329098404118 mL in 1 TUBE (53329-984-04) 118 ml2019-03-040000-00-00NoNoCurrent
53329-984-0653329098406473 mL in 1 BOTTLE (53329-984-06) 473 ml2019-03-040000-00-00NoNoCurrent
53329-984-16533290984165.6 mL in 1 PACKET (53329-984-16) 5.6 ml2019-03-040000-00-00NoNoCurrent
53329-984-2353329098423946 mL in 1 BOTTLE (53329-984-23) 946 ml2019-03-040000-00-00NoNoCurrent
53329-984-25533290984253785 mL in 1 BOTTLE (53329-984-25) 3785 ml2019-03-040000-00-00NoNoCurrent
53329-984-3053329098430100 PACKET in 1 BOX (53329-984-30) / 5.6 mL in 1 PACKET100 packet2019-03-040000-00-00NoNoCurrent