FDA.reportPublic FDA data

ZIKS ARTHRITIS PAIN RELIEF

Product NDC
63044-030
11-digit product format
630440030
Labeler code
63044
Product ID
63044-030_04c250af-b544-4861-b5a8-94c5d9c070ac
Type
HUMAN OTC DRUG
Nonproprietary name
ZIKS ARTHRITIS PAIN RELIEF
Dosage form
CREAM
Route
TOPICAL
Labeler
Nnodum Pharmaceuticals
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1999-11-10
Substance
METHYL SALICYLATE; MENTHOL; CAPSAICIN
Active strength
6.79; .566; .014 mg/g; mg/g; mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage63044-030-60e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63044-030-609bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage63044-030-60110d247fa046…a55b01930146…

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
ZIKS ARTHRITIS PAIN RELIEF
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYL SALICYLATE6.79 mg/g
MENTHOL.566 mg/g
CAPSAICIN.014 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
LAV5U5022YInternal UNII lookup
L7T10EIP3AInternal UNII lookup
S07O44R1ZMInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
283224Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5dd4fefc-b70a-4850-819c-1cca6f28aa97Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63044-030-602021-12-22C16284748780-1956f9ecf-c4f5-621f-e053-dbdaa90a74adArthritis Pain Relief Cream
63044-030-602019-10-21C16284748780-1956f9ecf-c4f5-621f-e053-dbdaa90a74adArthritis Pain Relief Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63044-030-60ZIKS ARTHRITIS PAIN RELIEF56.6 g in 1 TUBECREAM56.618

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63044-030-60GM - Gram63044-030b2ab0bbc-ca19-438f-a30a-db309312066c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAPSAICINACTIVE INGREDIENTS07O44R1ZMZIKS ARTHRITIS PAIN RELIEF CREAM [NNODUM PHARMACEUTICALS]5
MENTHOLACTIVE INGREDIENTL7T10EIP3AZIKS ARTHRITIS PAIN RELIEF CREAM [NNODUM PHARMACEUTICALS]5
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YZIKS ARTHRITIS PAIN RELIEF CREAM [NNODUM PHARMACEUTICALS]5
CAPSAICINACTIVE MOIETYS07O44R1ZMZIKS ARTHRITIS PAIN RELIEF CREAM [NNODUM PHARMACEUTICALS]5
MENTHOLACTIVE MOIETYL7T10EIP3AZIKS ARTHRITIS PAIN RELIEF CREAM [NNODUM PHARMACEUTICALS]5
METHYL SALICYLATEACTIVE MOIETYLAV5U5022YZIKS ARTHRITIS PAIN RELIEF CREAM [NNODUM PHARMACEUTICALS]5
CETETH-20INACTIVE INGREDIENTI835H2IHHXZIKS ARTHRITIS PAIN RELIEF CREAM [NNODUM PHARMACEUTICALS]5
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNZIKS ARTHRITIS PAIN RELIEF CREAM [NNODUM PHARMACEUTICALS]5
SORBITOLINACTIVE INGREDIENT506T60A25RZIKS ARTHRITIS PAIN RELIEF CREAM [NNODUM PHARMACEUTICALS]5
UREAINACTIVE INGREDIENT8W8T17847WZIKS ARTHRITIS PAIN RELIEF CREAM [NNODUM PHARMACEUTICALS]5
WATERINACTIVE INGREDIENT059QF0KO0RZIKS ARTHRITIS PAIN RELIEF CREAM [NNODUM PHARMACEUTICALS]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63044-030ZIKS ARTHRITIS PAIN RELIEF CREAM [NNODUM PHARMACEUTICALS]17Current NDC, Legacy NDC, 1 package rows20241230_5dd4fefc-b70a-4850-819c-1cca6f28aa97.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 19 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Biofreeze MentholMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLC3f2b1f48-2d78-4985-a046-9f72de5e1a9b2026-05-13WarningsExact identifier
application number: M017
BiofreezeMENTHOLReckitt Benckiser LLC10a8face-47da-ebbe-e063-6294a90a42fe2026-05-13WarningsExact identifier
application number: M017
Biofreeze Foot CreamMENTHOLReckitt Benckiser LLC32450cbf-4ed4-402b-a30e-e08a17bba3fb2026-05-13WarningsExact identifier
application number: M017
BiofreezeMENTHOLReckitt Benckiser LLCa227213b-e89f-7144-e053-2a95a90a7e742026-05-13WarningsExact identifier
application number: M017
BiofreezeMENTHOLReckitt Benckiser LLC00bb462a-27d0-6f74-e063-6394a90a90ec2026-05-13WarningsExact identifier
application number: M017
BioFreeze Dry StickMENTHOLReckitt Benckiser LLC26d62cd2-9209-8cca-e063-6394a90a20282026-05-13WarningsExact identifier
application number: M017
Biofreeze Foot Pain Relief SetMENTHOLReckitt Benckiser LLC4a885eef-0364-4655-bccc-7158c76cc5b22026-05-13WarningsExact identifier
application number: M017
Biofreeze Colorless Roll-OnMENTHOLReckitt Benckiser LLCa8d59d45-0e85-43d1-affd-bbe922c4acb12026-05-13WarningsExact identifier
application number: M017
Biofreeze ColorlessMENTHOLReckitt Benckiser LLC939dbbc3-71ec-4990-840e-7c9b8d4305622026-05-13WarningsExact identifier
application number: M017
Biofreeze Flexible Relief StripMENTHOLReckitt Benckiser LLC6ec26bae-e395-49aa-969e-8c653d6f0b272026-05-13WarningsExact identifier
application number: M017
Biofreeze Day and OvernightMENTHOLReckitt Benckiser LLCfb5c8f89-a720-ad32-e053-6294a90a2abe2026-05-13WarningsExact identifier
application number: M017
Biofreeze FoamMENTHOLReckitt Benckiser LLC890191e8-99ad-489c-8f21-2592f3d319362026-05-13WarningsExact identifier
application number: M017
Orajel Cold Sore Touch Free - Single DoseBENZALKONIUM CHLORIDE, BENZOCAINEChurch & Dwight Co., Inc.ce40829e-941f-2548-e053-2995a90a1e0e2026-05-13WarningsExact identifier
application number: M017
Lidocaine Pain Relief PatchLIDOCAINEGERI-CARE PHARMACEUTICAL CORP51b7753b-8619-6ea9-e063-6294a90a4ea42026-05-13WarningsExact identifier
application number: M017
DERMFREE Anti-itch CreamHYDROCORTISONE1% ANTI-ITCH CREAMJiangxi Zhongletang Pharmaceuticals Co.,Ltd.519c319a-9c43-0e63-e063-6394a90ab8692026-05-13WarningsExact identifier
application number: M017
Valtrum TOPICAL ANALGESICCAMPHOR, MENTHOL, METHYL SALICYLATELaboratorios Quantium LLCf3c4cc3a-f3a3-4d02-97e0-9c3fc1a67c3e2026-05-13WarningsExact identifier
application number: M017
Biofreeze Professional ColorlessMENTHOL, UNSPECIFIED FORMReckitt Benckiser4639201c-a67a-475f-8df6-3dc6225803ad2026-05-12WarningsExact identifier
application number: M017
Biofreeze Professional Colorless Roll-OnMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLCbae9946a-4c68-4759-9fb3-0a61a7ad0eb72026-05-12WarningsExact identifier
application number: M017
Instaflex Pain Relief CreamMENTHOLHealthy Directions, LLC665b847a-9cfb-49fc-975b-81c97f9365752026-05-12WarningsExact identifier
application number: M017
Theracare Cold Therapy Pain ReliefMENTHOLVeridian Healthcare51a5a043-07b6-1c96-e063-6394a90aa9262026-05-12WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283224capsaicin 0.025 % / menthol 1 % / methyl salicylate 12 % Topical CreamPSN5dd4fefc-b70a-4850-819c-1cca6f28aa9718
283224capsaicin 0.25 MG/ML / menthol 10 MG/ML / methyl salicylate 120 MG/ML Topical CreamSCD5dd4fefc-b70a-4850-819c-1cca6f28aa9718
283224capsaicin 0.025 % / menthol 1 % / methyl salicylate 12 % Topical CreamSY5dd4fefc-b70a-4850-819c-1cca6f28aa9718

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63044-030-606304400306056.6 g in 1 TUBE (63044-030-60) 56.6 g1999-11-100000-00-00NoNoCurrent