FDA.reportPublic FDA data

Anti-Itch Regular Strength

Product NDC
69842-192
11-digit product format
698420192
Labeler code
69842
Product ID
69842-192_4fb09ee0-a722-a491-e063-6394a90abba4
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrocortisone
Dosage form
CREAM
Route
TOPICAL
Labeler
CVS Pharmacy
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-03-02
Substance
HYDROCORTISONE
Active strength
5 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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
Anti-Itch Regular Strength
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCORTISONE5 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
198707Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9fe7768b-9023-c9ee-e053-2a95a90a55b3Available 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
2022-03-31CVS Hydrocortisone Cream w/Aloe 0.5% 2oz 27720 ZDP
2022-03-31CVS Hydrocortisone Cream w/Aloe 0.5% 2oz 27720 ZDP
2022-03-31CVS Hydrocortisone Cream w/Aloe 0.5% 2oz 27720 ZDP
2022-01-28CVS Hydrocortisone Cream w/Aloe 0.5% 2oz 27720 ZDP
2022-01-28CVS Hydrocortisone Cream w/Aloe 0.5% 2oz 27720 ZDP
2022-01-28CVS Hydrocortisone Cream w/Aloe 0.5% 2oz 27720 ZDP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-192-57Anti-Itch Regular Strength57 g in 1 TUBECREAM577
69842-192-57Anti-Itch Regular Strength1 in 1 CARTONCREAM17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69842-192-57GM - Gram69842-1921eefdf66-d086-4ca1-8562-960af44e5fa412024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-192ANTI-ITCH REGULAR STRENGTH (HYDROCORTISONE) CREAM [CVS PHARMACY]5Current NDC, Legacy NDC, 2 package rows20241212_9fe7768b-9023-c9ee-e053-2a95a90a55b3.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 62 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
XtraCare Skin Relief Oatmeal Daily MoisturizingDIMETHICONERejoice International5ae6d5d4-caff-4360-a0e7-7c8d7a9b59072024-02-28WarningsExact identifier
application number: M016
XtraCare with cooling action Oatmeal Skin Relief CalminDIMETHICONERejoice International29abd476-c32d-49f0-b283-30f4ba570ab42024-02-28WarningsExact identifier
application number: M016
MAX BARRIER Skin ProtectantZINC OXIDEGL HEALTH, INC.5eec834d-d8f3-49e3-b230-f8cf88b795e62024-02-26WarningsExact identifier
application number: M016
Rugby Petrolatum Hydrating Skin ProtectantPETROLATUMRugby Laboratoriesad63e345-1fe8-4f9a-a32e-8dfcde31bedc2024-02-12WarningsExact identifier
application number: M016
A and DPETROLATUMSafetec of America, Inc.b9afda3a-9e1d-46c1-b7aa-c3143caf709e2024-02-09WarningsExact identifier
application number: M016
Blistex Medicated Mint BalmDIMETHICONE, OCTINOXATE, AND OCTISALATEBlistex Inc86fc9f3c-e35f-4988-bf19-64d9c6c85ee92024-02-09WarningsExact identifier
application number: M016
Blistex Medicated Berry BalmDIMETHICONE, OCTINOXATE, AND OCTISALATEBlistex Inc827365b3-b3a5-4472-9add-f822362c47312024-02-09WarningsExact identifier
application number: M016
Blistex Medicated Lip BalmDIMETHICONE, OCTINOXATE, AND OCTISALATEBlistex Inc8b4160ed-8889-4e3a-947f-a56c3324dbbe2024-02-09WarningsExact identifier
application number: M016
MedlineWHITE PETROLATUM, ZINC OXIDEMedline Industries, LP101b9933-c2b8-0fdd-e063-6294a90a306a2024-01-29WarningsExact identifier
application number: M016
XtraCare Skin Relief Oatmeal Daily MoisturizingDIMETHICONERejoice International8d9e0893-c9be-4f5a-afc2-b5b997c8d1cc2024-01-29WarningsExact identifier
application number: M016
Cetaphil Baby HealingPETROLATUMGalderma Laboratories, L.P.5140754e-5db0-470f-adfd-de02b184880b2024-01-29WarningsExact identifier
application number: M016
CHAPSTICK CLASSIC MEDICATEDCAMPHOR, MENTHOL, PETROLATUMHaleon US Holdings LLCb4259621-ff41-46cc-a658-b57bff3c15252024-01-23WarningsExact identifier
application number: M016
Zinc Oxide 20%ZINC OXIDETrifecta Pharmaceuticals USAfcef17f1-84e7-a288-e053-6294a90a064b2024-01-19WarningsExact identifier
application number: M016
Hydro GelGLYCERIN 20%Trifecta Pharmaceuticals USA LLC02e8e5d0-7844-39fe-e063-6394a90a57e12024-01-19WarningsExact identifier
application number: M016
White PetrolatumWHITE PETROLATUMSled Distribution, LLCe73a4b7a-7b27-abfc-e053-2995a90a35c22024-01-15WarningsExact identifier
application number: M016
Sunmark CaldiphenCALAMINE AND PRAMOXINE HYDROCHLORIDEStrategic Sourcing Services4f4d4c54-64b5-4e20-bed0-c7fb470b84342024-01-12WarningsExact identifier
application number: M016
EIGHT HOUR NIGHTDIMETHICONEREVLONb3b277f9-565a-636c-e053-2995a90a94d22024-01-12WarningsExact identifier
application number: M016
CeraVe Developed with Dermatologists Eczema Relief CreamyOATMEALL'Oreal USA Products Incbcf7b985-6875-4033-a412-1bb6d3afa6d82024-01-01WarningsExact identifier
application number: M016
CeraVe Developed with Dermatologists HealingPETROLATUML'Oreal USA Products Inc.1b3ad3e8-cbac-4a92-84e2-4f3ab4512d952023-12-31WarningsExact identifier
application number: M016
CeraVe Developed with Dermatologists Baby HealingPETROLATUML'Oreal USA Products Inc.fe665bbc-1172-4f59-acc6-8d5c179693b62023-12-31WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198707hydrocortisone 0.5 % Topical CreamPSN9fe7768b-9023-c9ee-e053-2a95a90a55b37
198707hydrocortisone 5 MG/ML Topical CreamSCD9fe7768b-9023-c9ee-e053-2a95a90a55b37
198707hydrocortisone 0.5 % Topical CreamSY9fe7768b-9023-c9ee-e053-2a95a90a55b37

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-192-57698420192571 TUBE in 1 CARTON (69842-192-57) / 57 g in 1 TUBE1 tube2020-03-020000-00-00NoNoCurrent