FDA.reportPublic FDA data

Margarite Zinc Cream

Product NDC
76348-413
Requested package NDC
76348-413-02
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 · 7 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded 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 24 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
YOUR ANTI-ACNE SERUMSALICYLID ACIDSkin Ai, LLC410d1968-6931-7a48-e063-6294a90abb622025-10-13WarningsExact identifier
application number: M006
GENTLE ACNE SERUMSALICYLIC ACIDDrmtlgy, LLCa8e41339-3f3b-44ad-9b2f-1962d5f66f3d2025-10-10WarningsExact identifier
application number: M006
30 day Acne Treatment KitSALICYLIC ACID, BENZOYL PEROXIDECosmetic Enterprises Ltd039ac054-3eb2-5beb-e063-6394a90a561a2025-10-10WarningsExact identifier
application number: M006
Breakout Control BioelementsBENZOYL PEROXIDECosmetic Enterprises Ltd94462332-2169-4ea1-86b3-25ab9646c6e52025-10-10WarningsExact identifier
application number: M006
Anti Bac Acne ClearingBENZOYL PEROXIDECosmetic Enterprise Ltd7f6ee76b-c664-2ec4-e053-2991aa0a94882025-10-10WarningsExact identifier
application number: M006
Clear Acne Body Paulas ChoiceSALICYLIC ACIDCosmetic Enterprises Ltd46cb9ff7-0f8f-457f-b4bb-6f33502243752025-10-10WarningsExact identifier
application number: M006
Clear Exfoliating Solution Paulas ChoiceSALICYLIC ACIDCosmetic Enterprises Ltdf84a2b7e-1e02-450f-b290-b4f6f87cdb7a2025-10-10WarningsExact identifier
application number: M006
Starface Acne Spot TreatmentSALICYLIC ACIDStarface World, Inc.f8cfd5b0-317e-4646-9885-71ecad29ba1c2025-10-07WarningsExact identifier
application number: M006
Skin Bliss MistSALICYLIC ACIDMatrix Beauty LLCde280fa0-f993-4ccc-bc92-4a8311b5e7ee2025-10-07WarningsExact identifier
application number: M006
skinlycious Clear skin complete starter kitSALICYLIC ACIDSkinlycious Pte Ltdab1609b7-a10b-44f3-ab86-a615967b2a572025-10-03WarningsExact identifier
application number: M006
Skinlycious Clear Skin Essentials Starter kitSALICYLIC ACIDSkinlycious Pte Ltdaf2d8318-cbff-4317-adb7-828a92af78682025-10-03WarningsExact identifier
application number: M006
Skinlycious Glow ExfoliantSALICYLIC ACIDSkinlycious Pte Ltd4baa8342-e983-43bb-9864-caf14bff21e32025-10-03WarningsExact identifier
application number: M006
Viaderma Clear Acne TreatmentSALICYLIC ACIDViaDerma Distribution, Inc.aa62d4b5-1e46-41bf-a9b6-69ae005fd79a2025-10-02WarningsExact identifier
application number: M006
Caring Mill Acne Clearing CleanserSALICYLIC ACIDFSA Store Inc. (Caring Mills)4038bf3f-d6b9-48a2-e063-6394a90aea6b2025-10-02WarningsExact identifier
application number: M006
Killa Extra Strength 2 packSALICYLIC ACIDZitSticka, Inc.fc9922ba-5164-5837-e053-6294a90a3de52025-10-01WarningsExact identifier
application number: M006
Acne Toner SerumSALICYLIC ACIDDime Beauty Co, LLCe5c35684-e8b5-70fd-e053-2a95a90aedae2025-10-01WarningsExact identifier
application number: M006
Acne Spot TreatmentSALICYLIC ACIDDime Beauty Co, LLCf7fd3f24-7c27-b45b-e053-6394a90a50ae2025-10-01WarningsExact identifier
application number: M006
Creamy Foam CleanserSALICYLIC ACIDDime Beauty Co, LLCe39f41ed-0909-9f0e-e053-2995a90ab36a2025-10-01WarningsExact identifier
application number: M006
DETOX DROPS ACNE TONERACNE TONERKENDO HOLDINGS INC.35bcdb22-550e-b27c-e063-6294a90a2e5b2025-09-30WarningsExact identifier
application number: M006
Neutrogena Evenly Clear Acne ExfoliantSALICYLIC ACIDKenvue Brands LLC3f90696e-1ece-78be-e063-6294a90a5c6a2025-09-26WarningsExact 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
76348-413-02763480413021 TUBE in 1 BOX (76348-413-02) / 28 g in 1 TUBE (76348-413-01) 1 tube2015-10-130000-00-00NoNoCurrent