FDA.reportPublic FDA data

CVS Cools Itch Fast

Product NDC
59779-729
11-digit product format
597790729
Labeler code
59779
Product ID
59779-729_4253413e-385c-63ad-e063-6294a90ae488
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrocortisone
Dosage form
GEL
Route
TOPICAL
Labeler
CVS Pharmacy, Inc.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-10-13
Substance
HYDROCORTISONE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [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
CVS Cools Itch Fast
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCORTISONE1 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
WI4X0X7BPJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198706Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8a4544df-bbba-47d2-ada0-352757abc91fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
26f3d783-2cc1-4327-e77d-71804cf675a2Product name120140508
36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0Product name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fdProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2022-02-18CVS Cortisone Cooling Gel 1 oz 34084 ZDP
2022-02-18CVS Cortisone Cooling Gel 1 oz 34084 ZDP
2022-01-28CVS Cortisone Cooling Gel 1 oz 34084 ZDP
2022-01-28CVS Cortisone Cooling Gel 1 oz 34084 ZDP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59779-729-28CVS Cools Itch Fast1 in 1 PACKAGEGEL113
59779-729-28CVS Cools Itch Fast28 g in 1 TUBEGEL2813

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59779-729-28GM - Gram59779-7291da25a47-bc62-44c3-a17d-253f1c439d9d12017-12-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCORTISONEACTIVE INGREDIENTWI4X0X7BPJCVS COOLS ITCH FAST (HYDROCORTISONE) GEL [CVS PHARMACY, INC.]4
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJCVS COOLS ITCH FAST (HYDROCORTISONE) GEL [CVS PHARMACY, INC.]4
2-HYDROXYETHYL ACRYLATEINACTIVE INGREDIENT25GT92NY0CCVS COOLS ITCH FAST (HYDROCORTISONE) GEL [CVS PHARMACY, INC.]4
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XCVS COOLS ITCH FAST (HYDROCORTISONE) GEL [CVS PHARMACY, INC.]4
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OCVS COOLS ITCH FAST (HYDROCORTISONE) GEL [CVS PHARMACY, INC.]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCVS COOLS ITCH FAST (HYDROCORTISONE) GEL [CVS PHARMACY, INC.]4
ISOHEXADECANEINACTIVE INGREDIENT918X1OUF1ECVS COOLS ITCH FAST (HYDROCORTISONE) GEL [CVS PHARMACY, INC.]4
MAGNESIUM DISODIUM EDTAINACTIVE INGREDIENTNDT563S5VZCVS COOLS ITCH FAST (HYDROCORTISONE) GEL [CVS PHARMACY, INC.]4
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DCVS COOLS ITCH FAST (HYDROCORTISONE) GEL [CVS PHARMACY, INC.]4
MENTHYL LACTATE, (-)-INACTIVE INGREDIENT2BF9E65L7ICVS COOLS ITCH FAST (HYDROCORTISONE) GEL [CVS PHARMACY, INC.]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCVS COOLS ITCH FAST (HYDROCORTISONE) GEL [CVS PHARMACY, INC.]4
MONOMENTHYL GLUTARATE, (-)-INACTIVE INGREDIENT134PF6763YCVS COOLS ITCH FAST (HYDROCORTISONE) GEL [CVS PHARMACY, INC.]4
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MCVS COOLS ITCH FAST (HYDROCORTISONE) GEL [CVS PHARMACY, INC.]4
PPG-3 BENZYL ETHER MYRISTATEINACTIVE INGREDIENT8075L58MKOCVS COOLS ITCH FAST (HYDROCORTISONE) GEL [CVS PHARMACY, INC.]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCVS COOLS ITCH FAST (HYDROCORTISONE) GEL [CVS PHARMACY, INC.]4
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRCVS COOLS ITCH FAST (HYDROCORTISONE) GEL [CVS PHARMACY, INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RCVS COOLS ITCH FAST (HYDROCORTISONE) GEL [CVS PHARMACY, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-729CVS COOLS ITCH FAST (HYDROCORTISONE) GEL [CVS PHARMACY, INC.]12Current NDC, Legacy NDC, 2 package rows20241222_8a4544df-bbba-47d2-ada0-352757abc91f.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 70 · 1,384 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dermaka Infants and Kids Multi Purpose Skin ProtectantZINC OXIDEDermaka Skin Products LLCf84dfd55-db6c-4d75-be67-4d13a139e2092026-09-10WarningsExact identifier
application number: M016
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic MultipurposeDIMETHICONEL'Oreal USA Products Inc805cd262-2689-4818-8fed-ddefacbdde232026-09-10WarningsExact identifier
application number: M016
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Therapeutic MultipurposeDIMETHICONECosmetique Active Productiond19f482c-bec7-45aa-b22f-fe91a3dc717d2026-09-10WarningsExact identifier
application number: M016
Zinc OxideZINC OXIDECVS Pharmacy, Inc.35e67726-4527-4cd7-8e73-30325a32402c2026-09-09Warnings, Adverse reactionsExact identifier
application number: M016
Lanolin, PetrolatumLANOLIN, PETROLATUMCVS Pharmacy, Inc.606f65a8-08fd-4ab6-9d68-03ddf662bdf02026-09-09Warnings, Adverse reactionsExact identifier
application number: M016
Eczema Soothing Moisturizing CreamCOLLOIDAL OATMEALNice-Pak Products, LLC23548524-2e2e-4d1a-9ebb-6f86d6279e932026-09-09Warnings, Adverse reactionsExact identifier
application number: M016
Advanced HealingPETROLATUMWalgreen Co.22bd8e87-965c-466b-bb9b-7d4753e500bc2026-09-09Warnings, Adverse reactionsExact identifier
application number: M016
Drs. pharmacy Scar CreamALLANTOINOL PHARMA TECH, LLC Drs PHARMACYd0381034-8cf7-5e8d-e053-2995a90a9faa2026-09-09WarningsExact identifier
application number: M016
Drs. Pharmacy baby healingPETROLATUMOL PHARMA TECH, LLC Drs PHARMACY5b14ffa0-9486-a7fe-e063-6394a90ab3ed2026-09-09WarningsExact identifier
application number: M016
Wart RemoverGLYCERINShantou Ouhoe Technology Co., Ltd.5af3afe1-dad5-91b7-e063-6294a90ab95e2026-09-08WarningsExact identifier
application number: M016
MedlineDIMETHICONEMedline Industries, LP5afb3595-f014-153e-e063-6294a90ad34b2026-09-08WarningsExact identifier
application number: M016
MedlineDIMETHICONEMedline Industries, LP5afb59b4-491c-45bb-e063-6294a90a0ae62026-09-08WarningsExact identifier
application number: M016
ClaravieALUMINUM HYDROXIDE GELGentell LLC5afea757-8feb-f907-e063-6394a90a62592026-09-08WarningsExact identifier
application number: M016
Clear Anti ItchPRAMOXINE HCL, ZINC ACETATEUnited Natural Foods, Inc. dba UNFI242adc68-f9e0-4f69-a580-a107d1634b502026-09-04Warnings, Adverse reactionsExact identifier
application number: M016
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
application number: M016
FIRST AID BEAUTY FAB ULTRA REPAIR SKIN PROTECTANT KitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company5a9aaca8-474a-0393-e063-6394a90a5a3a2026-09-04WarningsExact identifier
application number: M016
Aveeno Eczema Therapy CreamCOLLOIDAL OATMEALKenvue Brands LLC5a7b0470-3ed5-5b92-e063-6294a90ae0f42026-09-03WarningsExact identifier
application number: M016
First Aid Beauty Face and Body Bestsellers KitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company5a974dbf-84ac-5374-e063-6294a90a8da02026-09-03WarningsExact identifier
application number: M016
Pure Petrolatum JellyPETROLATUMJell Pharmaceuticals Pvt. Ltd.cdc297cb-476a-6da9-e053-2a95a90a399a2026-09-02WarningsExact identifier
application number: M016
Nail Treatment LiquidGLYCERINShantou Ximonth Biotechnology Co., Ltd.5a7cd607-a50e-17d0-e063-6294a90acdb22026-09-02WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198706hydrocortisone 1 % Topical GelPSN8a4544df-bbba-47d2-ada0-352757abc91f13
198706hydrocortisone 0.01 MG/MG Topical GelSCD8a4544df-bbba-47d2-ada0-352757abc91f13
198706hydrocortisone 1 % Topical GelSY8a4544df-bbba-47d2-ada0-352757abc91f13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-729-28597790729281 TUBE in 1 PACKAGE (59779-729-28) / 28 g in 1 TUBE1 tube2014-10-130000-00-00NoNoCurrent