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 10 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EELHOE Cuticle Pusher PenGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.52c7f956-a2a1-ae1d-e063-6294a90ab3c22026-05-27WarningsExact identifier
application number: M016
Dermoia Eczema Relief Colloidal OatmealOATMEALTreasurewise LLC1285c0a4-5fdf-4691-a8c6-1de8e2e2f66a2026-05-27WarningsExact identifier
application number: M016
CalaclearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATEWal-Mart Stores, Inc.61e76e2a-fc46-7a64-e053-2991aa0a56a82026-05-26WarningsExact identifier
application number: M016
CalamineCALAMINE AND ZINC OXIDEWal-Mart Stores, Inc.61929c97-bd6b-0d7c-e053-2991aa0aa5712026-05-26WarningsExact identifier
application number: M016
CalamineCALAMINE AND ZINC OXIDEPharma Nobis, LLCfbcfa541-beda-06de-e053-6294a90a92982026-05-26WarningsExact identifier
application number: M016
Humco CalamineCALAMINE 8% AND ZINC OXIDE 8%Humco holding Group, Inc.f7dcd959-fb98-43bb-8dd3-a662bf8a053c2026-05-26WarningsExact identifier
application number: M016
Advanced HealingPETROLATUMCVS Pharamacy, Inc0bd3380e-2284-44a7-b2ef-68c9909627fd2026-05-26Warnings, Adverse reactionsExact identifier
application number: M016
CeraVe Developed with Dermatologists Healing Lip BalmPETROLATUML'Oreal USA Products Inc21dc8842-0672-4d46-bcea-b8e3d54c48bf2026-05-20WarningsExact identifier
application number: M016
AFTER CAREDIMETHICONEMerz North Americac19c5ffe-3b62-43e1-83c2-d89c7b9aa2ae2026-05-20WarningsExact identifier
application number: M016
Zinc Oxide 20%ZINC OXIDETrifecta Pharmaceuticals USA63b551fc-7d16-c099-e053-2a91aa0a5f2c2026-05-18WarningsExact identifier
application number: M016
ADVANCED SILICONE SCARALLANTOINYantai Aien Biotechnology Co., Ltd.51ffdc45-5acf-ae20-e063-6294a90a55e82026-05-17WarningsExact identifier
application number: M016
LCFateLC Nail LiquidGLYCERINShantou Ximonth Biotechnology Co., Ltd.51ea23f4-0a23-4ae1-e063-6394a90aa0512026-05-16WarningsExact identifier
application number: M016
Radlive Active Defense Nano-Silver CreamCOLLOIDAL OATMEALSilverCeuticals51e23135-008d-9db5-e063-6294a90a7d612026-05-15WarningsExact identifier
application number: M016
Cerave Developed with Dermatologists HealingPETROLATUMLOreal USA Products Incde44ac01-ba17-4f97-ac12-9ea348013bde2026-05-14WarningsExact identifier
application number: M016
Triple 3x Max Diaper RashZINC OXIDEAdvantice Health, LLCe554046b-cd0a-4a6e-8f24-2e610c6974322026-05-14WarningsExact identifier
application number: M016
Eczema TherapyCOLLOIDAL OATMEALSilverCeuticals3a26a35e-a098-0e22-e063-6294a90a96b92026-05-13WarningsExact identifier
application number: M016
Nail- PflasterGLYCERINShantou Ximonth Biotechnology Co., Ltd.519681bc-6312-f627-e063-6394a90a28452026-05-11WarningsExact identifier
application number: M016
HydratingPETROLATUMAldermed Inc.4aa6a354-e487-4b65-e063-6394a90abbf02026-05-09WarningsExact identifier
application number: M016
Diaper RashZINC OXIDEAldermed Inc.4aa79292-dc91-b538-e063-6294a90ac3f02026-05-09WarningsExact identifier
application number: M016
XIMONTH Nail Fungus Care LiquidGLYCERINShantou Ximonth Biotechnology Co., Ltd.514a998d-aa2a-46b6-e063-6294a90a6c222026-05-08WarningsExact 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