Margarite Zinc Cream

Product NDC
76348-413
11-digit product format
763480413
Labeler code
76348
Product ID
76348-413_373b8aa5-564e-3e75-e063-6394a90af372
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Cream
Dosage form
CREAM
Route
TOPICAL
Labeler
Renu Laboratories, LLC
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-10-13
Substance
SULFUR
Active strength
1.12 g/28g
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 · 14 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage76348-413-02IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage76348-413-02IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage76348-413-02IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage76348-413-02IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage76348-413-02UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage76348-413-02UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage76348-413-02UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
Margarite Zinc Cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFUR1.12 g/28g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
70FD1KFU70Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
247817Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3ca3b7d8-702a-036b-e054-00144ff8d46cAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76348-413-022025-06-10C16284748780-12cef2736-5b8b-d83d-e063-dadaa90ab31fMARGARITE ZINC CREAM
76348-413-022025-01-30C16284748780-12cef2736-5b8b-d83d-e063-dadaa90ab31fMARGARITE ZINC CREAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-413-01Margarite Zinc Cream28 g in 1 TUBECREAM2811
76348-413-02Margarite Zinc Cream1 in 1 BOXCREAM111

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76348-413MARGARITE ZINC CREAM (ZINC CREAM) CREAM [RENU LABORATORIES, INC.]10Current NDC, Legacy NDC, 2 package rows20220115_3ca3b7d8-702a-036b-e054-00144ff8d46c.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 46 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vichy Laboratoires Normaderm Daily Deep Cleansing Acne TreatmentSALICYLIC ACIDL'Oreal USA Products Inc74c49388-3314-47e8-80b1-19c09e6ea1f92024-07-14WarningsExact identifier
application number: M006
Vichy Laboratoires Normaderm Daily Deep Cleansing Acne TreatmentSALICYLIC ACIDCOSMETIQUE ACTIVE PRODUCTION873de079-8b8d-45cd-8c7c-4645818f5aaa2024-07-14WarningsExact identifier
application number: M006
Dr. Zenovia Clear ComplexionSALICYLIC ACIDTopiderm, Inc.4ff9b26d-3cd9-4539-b389-edd2df24a4662024-06-28WarningsExact identifier
application number: M006
LEROSETT Botanical Acne CleanserSALICYLIC ACIDGUNILLA OF SWEDEN, INC.8b31d155-c257-4452-9e22-0c69fa36173e2024-06-27WarningsExact identifier
application number: M006
SkinCeuticals Silymarin CF Acne Treatment AntioxidantSALICYLIC ACIDCosmetique Active Productionfcc3c44b-3090-45b5-91e4-e591c92a08c82024-06-24WarningsExact identifier
application number: M006
Peace Out Early Stage Acne DotSALICYLIC ACIDPeace Out LLC.0632d458-d326-ade4-e063-6294a90af3ba2024-06-20WarningsExact identifier
application number: M006
Replenix BP AcneBENZOYL PEROXIDETopiderm, Inc.f449e020-a4d8-4a1b-82eb-4dc59e99b8d42024-06-18WarningsExact identifier
application number: M006
b pure Pressed Powder for Acne Prone Skin FairSALICYLIC ACIDFourstar Group USA, Inc.ecf22bd1-4fc3-4455-ae01-13f97f53dc342024-06-17WarningsExact identifier
application number: M006
b pure Pressed Powder for Acne Prone Skin TanSALICYLIC ACIDFourstar Group USA, Inc.1158f6c2-2b59-4ed3-8d28-73b6da885a5d2024-06-17WarningsExact identifier
application number: M006
Gly-Sal 10-2SALICYLIC ACIDTopiderm, Inc.661cc58b-9360-4b96-b405-afdc2e3783972024-06-13WarningsExact identifier
application number: M006
BLAIR and JACK Anti-Bump Acne TreatmentBENZOYL PEROXIDEBlair + Jackaa8df86a-639c-4416-aadf-4b58566ed9f12024-06-11WarningsExact identifier
application number: M006
b pure Blemish Concealer for Acne Prone Skin NudeSALICYLIC ACIDFourstar Group USA, Inc.76e91277-1fb4-490b-b351-39d626bc1fc22024-06-11WarningsExact identifier
application number: M006
b pure Blemish Concealer for Acne Prone Skin FairSALICYLIC ACIDFourstar Group USA, Inc.764599e5-2ec3-4223-819e-36415fd915f72024-06-11WarningsExact identifier
application number: M006
Dr. Zenovia Acne CleanserBENZOYL PEROXIDETopiderm, Inc.00fb1ee5-6076-4980-8507-9e58a96e6a6b2024-06-11WarningsExact identifier
application number: M006
Dr. Zenovia Spot TreatmentBENZOYL PEROXIDETopiderm, Inc.dfdb3d8e-4d39-4ce4-851f-80b11972ca9e2024-06-11WarningsExact identifier
application number: M006
Rugby Benzoyl Peroxide Acne MedicationBENZOYL PEROXIDENuCare Pharmaceuticals,Inc.69bd4f4c-017a-7422-e053-2991aa0aa6552024-06-10WarningsExact identifier
application number: M006
Thayers Natural Remedies Since 1847 Rapid Acne TreatmentSULFURL'Oreal USA Products Incd7cc3c06-2f89-4c0b-b121-fdd53638b6252024-06-07WarningsExact identifier
application number: M006
Differin 10% BPO Acne TreatmentBENZOYL PEROXIDEGalderma Laboratories, L.P.05468eab-f239-42cb-9106-055a105f0fa52024-06-06WarningsExact identifier
application number: M006
2.5 Acne MedBENZOYL PEROXIDEFace Reality, Inc.58a7f677-996c-4951-8e5d-b5556244f8002024-06-05WarningsExact identifier
application number: M006
10 Acne MedBENZOYL PEROXIDEFace Reality, Inc.91791905-086f-44cf-9c1a-e9f132c6c11b2024-06-05WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
247817sulfur 4 % Topical CreamPSN3ca3b7d8-702a-036b-e054-00144ff8d46c11
247817sulfur 40 MG/ML Topical CreamSCD3ca3b7d8-702a-036b-e054-00144ff8d46c11
247817sulfur 4 % Topical CreamSY3ca3b7d8-702a-036b-e054-00144ff8d46c11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76348-413-017634804130128 g in 1 TUBE28 gHistorical
76348-413-02763480413021 TUBE in 1 BOX (76348-413-02) / 28 g in 1 TUBE (76348-413-01) 1 tube2015-10-130000-00-00NoNoCurrent