FDA.reportPublic FDA data

Capsaicin

Product NDC
68071-3430
Requested package NDC
68071-3430-2
11-digit product format
680713430
Labeler code
68071
Product ID
68071-3430_2d587184-fc1f-2fda-e063-6394a90a32fa
Type
HUMAN OTC DRUG
Nonproprietary name
Capsaicin
Dosage form
CREAM
Route
TOPICAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-03-01
Substance
CAPSAICIN
Active strength
.25 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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68071-343068071-3430-2UExcluded because listing certification expiredexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68071-343068071-3430-2UExcluded because listing certification expiredexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68071-343068071-3430-2UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

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
Capsaicin
Brand name suffix
External Analgesic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAPSAICIN.25 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198555Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fd90a67d-d60d-a849-e053-6394a90a2cc8Available 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
68071-3430-22025-03-04C16284748780-12cef2736-8896-d83d-e063-dadaa90ab31fRugby ® Capsaicin Cream External Analgesic
68071-3430-22025-01-30C16284748780-12cef2736-8896-d83d-e063-dadaa90ab31fRugby ® Capsaicin Cream External Analgesic

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3430-2CapsaicinExternal Analgesic60 g in 1 TUBECREAM602
68071-3430-2CapsaicinExternal Analgesic1 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3430CAPSAICIN EXTERNAL ANALGESIC (CAPSAICIN) CREAM [NUCARE PHARMACEUTICALS,INC.]2Current NDC, 2 package rows20250306_fd90a67d-d60d-a849-e053-6394a90a2cc8.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 31 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diphenhydramine Hydrochloride and Zinc AcetateDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATESTRATEGIC SOURCING SERVICES LLCec0c9602-35cc-4bb6-b853-794a8b5bf42e2026-03-03WarningsExact identifier
application number: M017
HYDROCORTISONEHYDROCORTISONE 1%PHARMACY CHOICE INC4cdfe8b6-c332-7bf8-e063-6394a90abaec2026-03-03WarningsExact identifier
application number: M017
HEEL PAIN RELIEF ROLL-ONLIDOCAINE AND MENTHOLGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.4c06c4a4-557b-8bb1-e063-6294a90a91252026-03-02WarningsExact identifier
application number: M017
Sunburn ReliefLIDOCAINE HCL 0.5%Old East Main Co.49173ec8-c94a-44c9-8a13-0f4b01b96cd62026-03-02Warnings, Adverse reactionsExact identifier
application number: M017
Itch ReliefDIPHENHYDRAMINE HCL, ZINC ACETATEOld East Main Co.6d87547f-bf4c-4dda-bd9d-32b576afd8052026-03-02Warnings, Adverse reactionsExact identifier
application number: M017
Still StandingMENTHOL, UNSPECIFIED FORMNatural Essentials Inc.66974aaf-c82f-4fe9-bfb3-3430b80ac9f22026-03-02WarningsExact identifier
application number: M017
Lightning Pain ReliefMENTHOLClinical Resolution Laboratory, Inc.80af21f5-dba8-42b0-8a65-ac5a94d83ca82026-03-02WarningsExact identifier
application number: M017
Icy Hot Lidocaine No-MessLIDOCAINE HYDROCHLORIDEChattem, Inc.347f9a18-8ab6-47d3-9610-5b4e9ca5d53a2026-03-02WarningsExact identifier
application number: M017
Gold Bond Maximum Strength Foot Pain ReliefLIDOCAINE HYDROCHLORIDEGold Bond Co LLC8e469076-2f5a-4de8-8d13-a38c072b9af82026-03-01WarningsExact identifier
application number: M017
HealthWise Pain Relief LidocaineLIDOCAINE HYDROCHLORIDEVeridian Healthcare48ecbab9-13e0-d0fa-e063-6294a90a6ff22026-02-28WarningsExact identifier
application number: M017
NUMBING CREAMSLIDOCAINEYongchun Lihui Trading Co., Ltd.3b5e1a74-5946-4f1f-e063-6394a90a404b2026-02-27WarningsExact identifier
application number: M017
Pain Relieving GelLIDOCAINE HYDROCHLORIDEChain Drug Marketing Associationb55b7253-2fd2-45cc-b94c-e92395ab0d2b2026-02-27Warnings, Adverse reactionsExact identifier
application number: M017
MEDISTIK PROFESSIONAL DUAL ACTIONMENTHOL, METHYL SALICYLATE, EUCALUPTUSNatureteq Inc.99c7f08a-ab14-4371-9147-189f75cb66332026-02-27WarningsExact identifier
application number: M017
Aloe Vera GelLIDOCAINE HCL, MENTHOLWalmart Inc.309dcf5b-7166-976a-e063-6394a90af9522026-02-27Warnings, Adverse reactionsExact identifier
application number: M017
ASYSTEM Radical Relief Gel Roll-OnMENTHOL, METHYL SALICYLATECosco International, Inc.7239733e-5510-4a63-96c3-dd88b4a431a32026-02-27WarningsExact identifier
application number: M017
Icy Hot Pro Pain Massaging BalmCAMPHOR AND MENTHOLChattem, Inc.09e2b0cb-5186-4f9c-b256-edaced4ca0142026-02-27WarningsExact identifier
application number: M017
Lidocaine Pain ReliefLIDOCAINE PAIN RELIEFPAI Holdings, LLC dba PAI Pharma963978de-8295-47ee-9b06-64c3521aa9942026-02-26WarningsExact identifier
application number: M017
Tommie Copper Cooling Roller Lavender ScentMENTHOL 4%Tommie Copper, Inc.4bbfd4d1-9036-bc20-e063-6394a90a3feb2026-02-26WarningsExact identifier
application number: M017
HQLSEY QUIT SMOKING PATCHESQUIT SMOKING PATCHESHansen Pharmaceutical Investment Co., Limited4ba317fb-714a-05cb-e063-6394a90a382f2026-02-25WarningsExact identifier
application number: M017
Advanced Pain Relief Cream With 5 % Natural MentholMENTHOLAllure Labs4bab9c43-86d4-dad2-e063-6394a90ac0952026-02-25WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198555capsaicin 0.025 % Topical CreamPSNfd90a67d-d60d-a849-e053-6394a90a2cc82
198555capsaicin 0.25 MG/ML Topical CreamSCDfd90a67d-d60d-a849-e053-6394a90a2cc82
198555capsaicin 0.025 % Topical CreamSYfd90a67d-d60d-a849-e053-6394a90a2cc82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3430-2680713430021 TUBE in 1 CARTON (68071-3430-2) / 60 g in 1 TUBE1 tube2023-06-07NoNoCurrent