Barrier Protectant Cream

Product NDC
63517-003
Requested package NDC
63517-003-32
11-digit product format
635170003
Labeler code
63517
Product ID
63517-003_3ce34f81-6708-c228-e063-6394a90a59d3
Type
HUMAN OTC DRUG
Nonproprietary name
Barrier Cream
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Cardinal Health
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-01-15
Substance
MENTHOL; ZINC OXIDE
Active strength
1; 200 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 17 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-278dfbde2a14a4…c9ff85d89658…

Additional Listing Data#

Finished product
Yes
Brand name base
Barrier Protectant Cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL1 mg/g
ZINC OXIDE200 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
539d9aac-75cf-4efd-bb3e-b465563304caAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63517-003-31Barrier Protectant Cream113 g in 1 TUBEOINTMENT1134
63517-003-32Barrier Protectant Cream57 g in 1 TUBEOINTMENT574
63517-003-34Barrier Protectant Cream5 g in 1 POUCHOINTMENT54
63517-003-34Barrier Protectant Cream150 in 1 BOXOINTMENT1504

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3ABARRIER PROTECTANT CREAM (BARRIER CREAM) OINTMENT [CARDINAL HEALTH]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZBARRIER PROTECTANT CREAM (BARRIER CREAM) OINTMENT [CARDINAL HEALTH]1
MENTHOLACTIVE MOIETYL7T10EIP3ABARRIER PROTECTANT CREAM (BARRIER CREAM) OINTMENT [CARDINAL HEALTH]1
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZBARRIER PROTECTANT CREAM (BARRIER CREAM) OINTMENT [CARDINAL HEALTH]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XBARRIER PROTECTANT CREAM (BARRIER CREAM) OINTMENT [CARDINAL HEALTH]1
CHAMOMILEINACTIVE INGREDIENTFGL3685T2XBARRIER PROTECTANT CREAM (BARRIER CREAM) OINTMENT [CARDINAL HEALTH]1
COD LIVER OILINACTIVE INGREDIENTBBL281NWFGBARRIER PROTECTANT CREAM (BARRIER CREAM) OINTMENT [CARDINAL HEALTH]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KBARRIER PROTECTANT CREAM (BARRIER CREAM) OINTMENT [CARDINAL HEALTH]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675BARRIER PROTECTANT CREAM (BARRIER CREAM) OINTMENT [CARDINAL HEALTH]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBARRIER PROTECTANT CREAM (BARRIER CREAM) OINTMENT [CARDINAL HEALTH]1
HONEYINACTIVE INGREDIENTY9H1V576FHBARRIER PROTECTANT CREAM (BARRIER CREAM) OINTMENT [CARDINAL HEALTH]1
LANOLININACTIVE INGREDIENT7EV65EAW6HBARRIER PROTECTANT CREAM (BARRIER CREAM) OINTMENT [CARDINAL HEALTH]1
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPBARRIER PROTECTANT CREAM (BARRIER CREAM) OINTMENT [CARDINAL HEALTH]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TBARRIER PROTECTANT CREAM (BARRIER CREAM) OINTMENT [CARDINAL HEALTH]1
MICROCRYSTALLINE WAXINACTIVE INGREDIENTXOF597Q3KYBARRIER PROTECTANT CREAM (BARRIER CREAM) OINTMENT [CARDINAL HEALTH]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UBARRIER PROTECTANT CREAM (BARRIER CREAM) OINTMENT [CARDINAL HEALTH]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHBARRIER PROTECTANT CREAM (BARRIER CREAM) OINTMENT [CARDINAL HEALTH]1
SODIUM BORATEINACTIVE INGREDIENT91MBZ8H3QOBARRIER PROTECTANT CREAM (BARRIER CREAM) OINTMENT [CARDINAL HEALTH]1
SORBITAN MONOOLEATEINACTIVE INGREDIENT06XEA2VD56BARRIER PROTECTANT CREAM (BARRIER CREAM) OINTMENT [CARDINAL HEALTH]1
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P8BARRIER PROTECTANT CREAM (BARRIER CREAM) OINTMENT [CARDINAL HEALTH]1
WATERINACTIVE INGREDIENT059QF0KO0RBARRIER PROTECTANT CREAM (BARRIER CREAM) OINTMENT [CARDINAL HEALTH]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63517-003BARRIER PROTECTANT CREAM (BARRIER CREAM) OINTMENT [CARDINAL HEALTH]3Current NDC, Legacy NDC, 4 package rows20200131_539d9aac-75cf-4efd-bb3e-b465563304ca.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 22 · 434 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gembooxt Topical Numbing CreamLIDOCAINEGuangdong Quadrant Ecological Technology Co., Ltd.49951a3e-3b62-3d66-e063-6294a90a93602026-08-12WarningsExact identifier
application number: M015
NumbMD Lidocaine Cream Anorectal(hemorrhoidal)LIDOCAINE 5%EveryMarket Inc52379055-d017-4d98-e063-6294a90a196c2026-08-12WarningsExact identifier
application number: M015
Nupharmisto NumbMD Lidocaine CreamLIDOCAINE 5%EveryMarket Inc52369a41-820d-cd7a-e063-6394a90ac6d12026-08-12WarningsExact identifier
application number: M015
Nupharmisto NumbMD Lidocaine CreamLIDOCAINE 5%EveryMarket Inc51d370b4-1c34-d203-e063-6394a90a80b12026-08-12WarningsExact identifier
application number: M015
Nupharmisto NumbMD 5% Lidocaine creamLIDOCAINE 5%EveryMarket Inc507d0c2c-9517-40f8-e063-6394a90a19962026-08-12WarningsExact identifier
application number: M015
Nupharmisto NumbMD LIDOCAINE cream anorectal (hemorrhoidal)LIDOCAINE CREAM ANORECTALEveryMarket Inc483d81a3-7493-3391-e063-6394a90a2e3d2026-08-12WarningsExact identifier
application number: M015
Numbing CreamLIDOCAINE100 KARMA INC35b5ba9d-da1d-55d6-e063-6294a90a5fa82026-08-12WarningsExact identifier
application number: M015
Treatonic hemorrhoid treatment5% LIDOCAINE100 KARMA INC41442fa7-c511-07ca-e063-6294a90a39922026-08-12WarningsExact identifier
application number: M015
Lidocaine numbing cream5% LIDOCAINE100 KARMA INC47380721-6633-4a50-e063-6394a90aca942026-08-12WarningsExact identifier
application number: M015
Treatonic 5% Lidocaine Cream5% LIDOCAINE CREAM100 KARMA INC47dc7630-9a74-1989-e063-6294a90a50bb2026-08-12WarningsExact identifier
application number: M015
Treatonic 5% Lidocaine Cream5% LIDOCAINE CREAM100 KARMA INC49e6b69f-bd6e-b415-e063-6394a90a8e652026-08-12WarningsExact identifier
application number: M015
THE SOLU TIONLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE HYDROCHLORIDESCALP TECH INC58793581-8826-9a74-e063-6294a90a24652026-08-06WarningsExact identifier
application number: M015
Lidocaine Numbing CreamLIDOCAINEGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.5457b3d7-e6b6-34a7-e063-6394a90aa2402026-08-03WarningsExact identifier
application number: M015
HEMORRHOIDALCREAMPROCUREPHENYLEPHRINE HCL, PETROLATUM, MINERAL OILTWIN MED, LLCe9c44756-1c98-41be-e053-2995a90a35b42026-08-03WarningsExact identifier
application number: M015
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEYYBA CORP582a0001-da1e-909a-e063-6394a90a2b112026-08-03WarningsExact identifier
application number: M015
up and upPHENYLEPHRINE HYDROCHLORIDETarget Corporationb42775ae-44fe-487e-b9ca-21d9687020a92026-07-29WarningsExact identifier
application number: M015
Acolye Numbing Cream Anorectal(Hemorrhoidal) CreamLIDOCAINEGuangdong Aimu Biological Technology Co., Ltd578fa642-ff30-e511-e063-6294a90a59872026-07-26WarningsExact identifier
application number: M015
CVS Topical Anesthetic HemorrhoidalDIBUCAINECVS PHARMACY, INC9f3d4fdb-ad82-4ab8-8a9e-252d027068ab2026-07-25WarningsExact identifier
application number: M015
Moisture BarrierMENTHOL 0.44%, ZINC OXIDE 20.6%Walgreen Company258f3392-0f42-21e8-e063-6294a90ae9ad2026-07-22WarningsExact identifier
application number: M015
RectaEase Hemorrhoid Relief CreamLIDOCAINETrifecta Pharmaceuticals USA LLCc054921a-9f1b-7c75-e053-2995a90a17382026-07-20WarningsExact identifier
application number: M015

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63517-003-326351700033257 g in 1 TUBE (63517-003-32) 57 g2015-01-150000-00-00NoNoCurrent