FDA.reportPublic FDA data

CoreTex Anti-Itch Gel

Product NDC
65753-400
11-digit product format
657530400
Labeler code
65753
Product ID
65753-400_f0da58ed-09ac-115a-e053-2995a90aa002
Type
HUMAN OTC DRUG
Nonproprietary name
camphor, diphenhydramine, zinc acetate
Dosage form
GEL
Route
TOPICAL
Labeler
CoreTex Products Inc
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2019-11-25
Marketing end
0000-00-00
Substance
CAMPHOR (SYNTHETIC); DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE
Active strength
0 g/100mL; g/100mL; g/100mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct65753-400DDiscontinued by firm2026-10-05
excluded packagepackage65753-40065753-400-02DDiscontinued by firm2026-10-05
excluded packagepackage65753-40065753-400-04DDiscontinued by firm2026-10-05
excluded packagepackage65753-40065753-400-13DDiscontinued by firm2026-10-05
excluded packagepackage65753-40065753-400-14DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65753-400-02CoreTex Anti-Itch Gel59 mL in 1 BOTTLEGEL596
65753-400-04CoreTex Anti-Itch Gel177 mL in 1 BOTTLEGEL1776
65753-400-13CoreTex Anti-Itch Gel1 mL in 1 POUCHGEL16
65753-400-13CoreTex Anti-Itch Gel25 in 1 CONTAINERGEL256
65753-400-14CoreTex Anti-Itch Gel300 in 1 CONTAINERGEL3006
65753-400-14CoreTex Anti-Itch Gel1 mL in 1 POUCHGEL16
65753-400-39CoreTex Professional Outdoor Skin Protection Wallet1 mL in 1 POUCHGEL1 mL2 g in 100mL3
65753-400-39CoreTex Professional Outdoor Skin Protection Wallet Refill1 mL in 1 POUCHGEL1 mL0.1 g in 100mL1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65753-400CORETEX ANTI-ITCH GEL (CAMPHOR, DIPHENHYDRAMINE, ZINC ACETATE) GEL [CORETEX PRODUCTS INC]6Legacy NDC, 6 package rows20241008_9849da49-d867-fae5-e053-2a95a90a399c.zip
65753-400CORETEX PROFESSIONAL OUTDOOR SKIN PROTECTION WALLET KIT [CORETEX PRODUCTS INC]2Legacy NDC20241008_f57bc089-405b-cdcd-e053-2995a90a9d12.zip
65753-400CORETEX PROFESSIONAL OUTDOOR SKIN PROTECTION WALLET REFILL KIT [CORETEX PRODUCTS INC]1Legacy NDC20231105_095855ef-85f5-dacd-e063-6294a90a597c.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CoreTex Anti-Itch GelCAMPHOR, DIPHENHYDRAMINE, ZINC ACETATECoreTex Products Inc9849da49-d867-fae5-e053-2a95a90a399c2024-10-06WarningsExact identifier
ndc (product): 65753-400

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2263170camphor 0.1 % / diphenhydrAMINE HCl 2 % / zinc acetate 1 % Topical GelPSN9849da49-d867-fae5-e053-2a95a90a399c6
2263170camphor 0.001 MG/MG / diphenhydramine hydrochloride 0.02 MG/MG / zinc acetate 0.01 MG/MG Topical GelSCD9849da49-d867-fae5-e053-2a95a90a399c6
2263170camphor 0.001 MG/MG / diphenhydramine HCl 0.02 MG/MG / zinc acetate 0.01 MG/MG Topical GelSY9849da49-d867-fae5-e053-2a95a90a399c6
2263170camphor 0.1 % / diphenhydramine HCl 2 % / zinc acetate 1 % Topical GelSY9849da49-d867-fae5-e053-2a95a90a399c6
1043353benzocaine 6 % Medicated PadPSNf57bc089-405b-cdcd-e053-2995a90a9d123
2263170camphor 0.1 % / diphenhydrAMINE HCl 2 % / zinc acetate 1 % Topical GelPSNf57bc089-405b-cdcd-e053-2995a90a9d123
582753ethanol 70 % Topical SolutionPSNf57bc089-405b-cdcd-e053-2995a90a9d123
2263166StingX 6 % Topical SwabPSNf57bc089-405b-cdcd-e053-2995a90a9d123
2263166benzocaine 60 MG/ML Medicated Pad [StingX]SBDf57bc089-405b-cdcd-e053-2995a90a9d123
1043353benzocaine 60 MG/ML Medicated PadSCDf57bc089-405b-cdcd-e053-2995a90a9d123
2263170camphor 0.001 MG/MG / diphenhydramine hydrochloride 0.02 MG/MG / zinc acetate 0.01 MG/MG Topical GelSCDf57bc089-405b-cdcd-e053-2995a90a9d123
582753ethanol 0.7 ML/ML Topical SolutionSCDf57bc089-405b-cdcd-e053-2995a90a9d123
1043353benzocaine 6 % Medicated WipeSYf57bc089-405b-cdcd-e053-2995a90a9d123
1043353benzocaine 6 % Topical SwabSYf57bc089-405b-cdcd-e053-2995a90a9d123
2263170camphor 0.001 MG/MG / diphenhydramine HCl 0.02 MG/MG / zinc acetate 0.01 MG/MG Topical GelSYf57bc089-405b-cdcd-e053-2995a90a9d123
2263170camphor 0.1 % / diphenhydramine HCl 2 % / zinc acetate 1 % Topical GelSYf57bc089-405b-cdcd-e053-2995a90a9d123
582753ethanol 70 % Topical SolutionSYf57bc089-405b-cdcd-e053-2995a90a9d123
582753ethyl alcohol 70 % Topical SolutionSYf57bc089-405b-cdcd-e053-2995a90a9d123
2263166StingX 60 MG/ML Medicated PadSYf57bc089-405b-cdcd-e053-2995a90a9d123
1043353benzocaine 6 % Medicated PadPSN095855ef-85f5-dacd-e063-6294a90a597c1
2263170camphor 0.1 % / diphenhydrAMINE HCl 2 % / zinc acetate 1 % Topical GelPSN095855ef-85f5-dacd-e063-6294a90a597c1
1039474ethanol 62.5 % Topical SolutionPSN095855ef-85f5-dacd-e063-6294a90a597c1
2263166StingX 6 % Topical SwabPSN095855ef-85f5-dacd-e063-6294a90a597c1
2263166benzocaine 60 MG/ML Medicated Pad [StingX]SBD095855ef-85f5-dacd-e063-6294a90a597c1
1043353benzocaine 60 MG/ML Medicated PadSCD095855ef-85f5-dacd-e063-6294a90a597c1
2263170camphor 0.001 MG/MG / diphenhydramine hydrochloride 0.02 MG/MG / zinc acetate 0.01 MG/MG Topical GelSCD095855ef-85f5-dacd-e063-6294a90a597c1
1039474ethanol 0.625 ML/ML Topical SolutionSCD095855ef-85f5-dacd-e063-6294a90a597c1
1043353benzocaine 6 % Medicated WipeSY095855ef-85f5-dacd-e063-6294a90a597c1
1043353benzocaine 6 % Topical SwabSY095855ef-85f5-dacd-e063-6294a90a597c1
2263170camphor 0.001 MG/MG / diphenhydramine HCl 0.02 MG/MG / zinc acetate 0.01 MG/MG Topical GelSY095855ef-85f5-dacd-e063-6294a90a597c1
2263170camphor 0.1 % / diphenhydramine HCl 2 % / zinc acetate 1 % Topical GelSY095855ef-85f5-dacd-e063-6294a90a597c1
1039474ethanol 62.5 % Topical SolutionSY095855ef-85f5-dacd-e063-6294a90a597c1
2263166StingX 60 MG/ML Medicated PadSY095855ef-85f5-dacd-e063-6294a90a597c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65753-400-026575304000259 mL in 1 BOTTLE (65753-400-02) 59 ml2019-11-260000-00-00NoNoCurrent
65753-400-0465753040004177 mL in 1 BOTTLE (65753-400-04) 177 ml2019-11-260000-00-00NoNoCurrent
65753-400-136575304001325 POUCH in 1 CONTAINER (65753-400-13) > 1 mL in 1 POUCH25 pouch2019-11-260000-00-00NoNoCurrent
65753-400-1465753040014300 POUCH in 1 CONTAINER (65753-400-14) > 1 mL in 1 POUCH300 pouch2019-11-260000-00-00NoNoCurrent
65753-400-39657530400391 mL in 1 POUCH1 mlHistorical