FDA.reportPublic FDA data

Capsaicin

Product NDC
50488-1025
11-digit product format
504881025
Labeler code
50488
Product ID
50488-1025_1eb282ca-46c9-4da5-b2e8-40819f4a6677
Type
HUMAN OTC DRUG
Nonproprietary name
Capsaicin
Dosage form
CREAM
Route
TOPICAL
Labeler
Alexso, Inc
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-10-01
Substance
CAPSAICIN
Active strength
.025 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
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
Capsaicin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAPSAICIN.025 g/100g

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
433da27d-04fb-481a-bbb0-874bb72c806aAvailable on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50488-1025-1Capsaicin1 in 1 CARTONCREAM16
50488-1025-1Capsaicin120 g in 1 TUBECREAM1206
50488-1025-2Capsaicin1 in 1 CARTONCREAM16
50488-1025-2Capsaicin25 g in 1 TUBECREAM256
50488-1025-5Capsaicin1 in 1 CARTONCREAM16
50488-1025-5Capsaicin50 g in 1 TUBECREAM506

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50488-1025-1GM - Gram50488-1025d17846c1-27c2-4422-951e-81c30af4e47b12018-11-06
50488-1025-2GM - Gram50488-1025990eddfb-a7a5-4493-b6e9-371140c2fd9d12019-10-07
50488-1025-5GM - Gram50488-10259795f0e9-7933-4d81-9bc2-c7b3efa42c3812018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50488-1025CAPSAICIN CREAM [ALEXSO, INC]6Current NDC, Legacy NDC, 6 package rows20241208_433da27d-04fb-481a-bbb0-874bb72c806a.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 58 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AleveXCAMPHOR AND MENTHOLBayer HealthCare LLCbc66bc1b-c0d5-2481-e053-2a95a90a75de2025-12-04WarningsExact identifier
application number: M017
AleveXCAMPHOR AND MENTHOLBayer HealthCare LLCbafd199a-e198-d5d1-e053-2995a90ad1cb2025-12-04WarningsExact identifier
application number: M017
AleveXCAMPHOR AND MENTHOLBayer HealthCare LLCbafdf06b-25f5-e29e-e053-2a95a90a5e1b2025-12-04WarningsExact identifier
application number: M017
MilagrosoMETHYL SALICYLATEPharmadel LLCfdcc8f44-afa0-3af0-e053-6394a90aa46d2025-12-04WarningsExact identifier
application number: M017
Alocane MaxLIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDEQuest Products LLC0a35221a-2fcb-2735-e063-6294a90a88ca2025-12-04WarningsExact identifier
application number: M017
Pain RelievingTROLAMINE SALICYLATECARDINAL HEALTH 110, LLC. DBA LEADERb813262e-57c6-4d2c-8cc0-7a17f6f593432025-12-04WarningsExact identifier
application number: M017
Gold Bond Medicated Extra Strength BodyMENTHOLGold Bond Co LLC7b75b7de-9c0b-4edf-b923-320f7d2bb1e62025-12-04WarningsExact identifier
application number: M017
Lidocaine PatchLIDOCAINEShenzhen Finona Information Technology Co., Ltd38767081-7011-6602-e063-6394a90a27842025-12-03WarningsExact identifier
application number: M017
4% Lidocaine Maximum Strength Pain ReliefLIDOCAINEShenzhen Finona Information Technology Co., Ltd3e5a5165-a773-0501-e063-6294a90ae2f42025-12-03WarningsExact identifier
application number: M017
Leader LidocaineLIDOCAINE HCLCARDINAL HEALTHcece6765-0e2f-5ce9-e053-2995a90a37582025-12-03WarningsExact identifier
application number: M017
Westlake LidocaineLIDOCAINE HCLWestlake Pharma LLC0c586a14-1a2a-9f42-e063-6294a90a16c12025-12-03WarningsExact identifier
application number: M017
CVS Lidocaine Maximum StrengthLIDOCAINE HCLCVS Pharmacy87490c0f-a4d9-740e-e053-2a95a90a47242025-12-03WarningsExact identifier
application number: M017
CVS Maximum Strength BurnLIDOCAINE HYDROCHLORIDE 4%CVS Pharmacy4510f379-c5a4-92c3-e063-6294a90a0a322025-12-03WarningsExact identifier
application number: M017
LidoPatch Pain ReliefLIDOCAINE, MENTHOLJAR Laboratories07289aa1-43ed-df31-e063-6394a90a764a2025-12-03WarningsExact identifier
application number: M017
Equate Pain Relief Cream4% LIDOCAINE HCLWalmart, Inc7d8e8a9a-5474-4c7b-e053-2991aa0a29f52025-12-03WarningsExact identifier
application number: M017
Solarcaine Burn Pain Relief 4ozSOLARCAINE BURN PAIN RELIEF 4OZWellSpring Pharmaceutical Corporation14f23c28-c713-4868-9f46-66363bf94b2c2025-12-03WarningsExact identifier
application number: M017
ElixirCortiReliefHYDROCORTISONEELIXIR HEALTHCARE USA, LLC.a6ca66f3-9759-4c98-a758-45700bc083522025-12-02WarningsExact identifier
application number: M017
Pain Relief Gel-PatchLIDOCAINE 4%Trifecta Pharmaceuticals USA, LLC.12a27ce7-c547-7134-e063-6394a90a94bd2025-12-02WarningsExact identifier
application number: M017
5Kind DMSOMENTHOL, METHYL SALICYLATE5KIND TRADING LTD6a6c7241-f544-4784-9581-f5b172fdbec72025-12-02WarningsExact identifier
application number: M017
PEDIADERMICS ECZEMA 2HYDROCORTISONERENU LABORATORIES, LLCda840bf6-ed65-bafc-e053-2a95a90a92d52025-12-02WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198555capsaicin 0.025 % Topical CreamPSN433da27d-04fb-481a-bbb0-874bb72c806a6
198555capsaicin 0.25 MG/ML Topical CreamSCD433da27d-04fb-481a-bbb0-874bb72c806a6
198555capsaicin 0.025 % Topical CreamSY433da27d-04fb-481a-bbb0-874bb72c806a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50488-1025-1504881025011 TUBE in 1 CARTON (50488-1025-1) / 120 g in 1 TUBE1 tube2018-10-010000-00-00NoNoCurrent
50488-1025-2504881025021 TUBE in 1 CARTON (50488-1025-2) / 25 g in 1 TUBE1 tube2018-10-010000-00-00NoNoCurrent
50488-1025-5504881025051 TUBE in 1 CARTON (50488-1025-5) / 50 g in 1 TUBE1 tube2018-10-010000-00-00NoNoCurrent