FDA.reportPublic FDA data

CoreTex Anti-Itch Gel

Product NDC
65753-400
11-digit product format
657530400
Labeler code
65753
Product ID
65753-400_23d94b44-5be0-f9fc-e063-6294a90a1e74
Type
HUMAN OTC DRUG
Nonproprietary name
camphor, diphenhydramine, zinc acetate
Dosage form
GEL
Route
TOPICAL
Labeler
CoreTex Products Inc
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-11-25
Substance
CAMPHOR (SYNTHETIC); DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE
Active strength
.1; 2; 1 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CoreTex Anti-Itch Gel
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (SYNTHETIC).1 g/100mL
DIPHENHYDRAMINE HYDROCHLORIDE2 g/100mL
ZINC ACETATE1 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5TJD82A1ET, TC2D6JAD40, FM5526K07A
Rxcui2263170

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]6Current NDC, Legacy NDC, 6 package rows20241008_9849da49-d867-fae5-e053-2a95a90a399c.zip
65753-400CORETEX PROFESSIONAL OUTDOOR SKIN PROTECTION WALLET KIT [CORETEX PRODUCTS INC]2Current NDC, Legacy NDC20241008_f57bc089-405b-cdcd-e053-2995a90a9d12.zip
65753-400CORETEX PROFESSIONAL OUTDOOR SKIN PROTECTION WALLET REFILL KIT [CORETEX PRODUCTS INC]1Current NDC, Legacy NDC20231105_095855ef-85f5-dacd-e063-6294a90a597c.zip

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