FDA.reportPublic FDA data

Stallion

Product NDC
83608-100
11-digit product format
836080100
Labeler code
83608
Product ID
83608-100_434a5ed6-79b6-8b19-e063-6394a90a4d90
Type
HUMAN OTC DRUG
Nonproprietary name
Delay Creme
Dosage form
CREAM
Route
TOPICAL
Labeler
Novelties by Nasswalk, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-08-07
Substance
BENZOCAINE
Active strength
5 g/100mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
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
Stallion
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE5 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U3RSY48JW5Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0261ec88-8fe4-d5f8-e063-6294a90ab3d4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83608-100-05Stallion1 in 1 CARTONCREAM13
83608-100-05Stallion0.5 mL in 1 TUBECREAM0.53
83608-100-15Stallion1 in 1 CARTONCREAM13
83608-100-15Stallion1.5 mL in 1 TUBECREAM1.53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83608-100STALLION (DELAY CREME) CREAM [NOVELTIES BY NASSWALK, INC.]2Current NDC, 4 package rows20241123_0261ec88-8fe4-d5f8-e063-6294a90ab3d4.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83608-100-05836080100051 TUBE in 1 CARTON (83608-100-05) / .5 mL in 1 TUBE1 tube2023-08-07NoNoCurrent
83608-100-15836080100151 TUBE in 1 CARTON (83608-100-15) / 1.5 mL in 1 TUBE1 tube2023-08-07NoNoCurrent