FDA.reportPublic FDA data

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
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 29 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr.Harry COMFORT ZONE CreamLIDOCAINE 4% PHENYLEPHRINE HCL 0.25% COMFORT ZONE CREAMJiangxi Yudexi Pharmaceutical Co., LTD4d32b89f-72e8-bc93-e063-6394a90a0bc82026-03-17WarningsExact identifier
application number: M017
MiloRod Ultra Muscle Rub Fast-Acting Pain ReliefCAPSAICIN, MENTHOLMilo Rod Import & Export, Inc.c3622dc3-0c05-47c9-b70b-4989467819062026-03-17WarningsExact identifier
application number: M017
Walgreens Burn PadBURN PADWalgreens3f8d7624-cf1e-1992-e063-6294a90a38062026-03-17Boxed warning, WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEMericon Industries8f351b04-8f6d-4353-9100-13a8a80d656a2026-03-17WarningsExact identifier
application number: M017
Shoe Pain ReliefLIDOCAINE HCI 4%Sole Amie0f2ccd5f-b9f4-40fc-b82f-173b0f19bf402026-03-16WarningsExact identifier
application number: M017
CVS Muscle BalmMENTHOL, CAMPHORCVS Health42796fc4-03be-3b02-e063-6394a90af2ab2026-03-16WarningsExact identifier
application number: M017
Crane Safety HydrocortisoneHYDROCORTISONECrane Safety LLC96d9527d-9bf7-ce82-e053-2995a90aff0c2026-03-16WarningsExact identifier
application number: M017
CVS Health Pain Relief FootMENTHOL, UNSPECIFIED FORMNATURAL ESSENTIALS, INC.0f646876-69d0-49db-ade2-2b3eb26dd3992026-03-16WarningsExact identifier
application number: M017
Walgreens Cold Therapy Pain Relief Foot CreamMENTHOLWalgreen Co.3bc8ece3-d555-3efb-e063-6394a90a19812026-03-16WarningsExact identifier
application number: M017
RICHTOFIT RAPID ACTIVE LEG AND FOOTMENTHOLRICHTOFIT LIMITED LIABILITY COMPANY4c357696-ca96-e6ad-e063-6294a90aaadb2026-03-16WarningsExact identifier
application number: M017
Xpect Stopain ClinicalMENTHOLCintas Corporation348e6062-b31e-435e-a153-6aa868b50efa2026-03-13WarningsExact identifier
application number: M017
DGH GREASELESS MUSCLE RUB ANALGESICMENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATEDOLLAR GENERAL225abfe0-ec72-4667-96b2-7657e989672b2026-03-13WarningsExact identifier
application number: M017
CVS Professional Pain ReliefMENTHOLCVS Pharmacy48836a5b-0baa-b7ee-e063-6294a90ac12b2026-03-13WarningsExact identifier
application number: M017
Keeps Climax DelayLIDOCAINE HYDROCHLORIDECosco International, Inc.3bfd3173-2dac-40a9-aec3-982b1d47d8fa2026-03-12WarningsExact identifier
application number: M017
NanoX Pain RelievingMENTHOL, METHYL SALICYLATEMG Science Technologies LLC4cc38927-8a8c-2df3-e063-6294a90aa0c12026-03-12WarningsExact identifier
application number: M017
Hand SanitizerALCOHOLProStat First Aid4cd4c51c-88bb-3797-e063-6294a90a8f702026-03-12WarningsExact identifier
application number: M017
CVS Lidocaine Pain ReliefLIDOCAINE HYDROCHLORIDE, MENTHOLCVS Pharmacy48c045ae-56b5-62c2-e063-6394a90aaf442026-03-12WarningsExact identifier
application number: M017
Hydrocortisone 1%HYDROCORTISONEProStat First Aid4cd62cba-075a-7448-e063-6394a90ab48d2026-03-12WarningsExact identifier
application number: M017
Medicated Pain Relief PatchCAMPHOR, MENTHOL, METHYL SALICYLATEKroger Company47cc4b05-a937-4624-bf41-85b8bd7c049e2026-03-12WarningsExact identifier
application number: M017
Lidocaine HCLLIDOCAINE HCLMatthias Therapeutics, LLC4cdb27b5-9178-0328-e063-6394a90a50b52026-03-12WarningsExact 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