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 19 of 56 · 1,101 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
clear days ahead oil-free salicylic acid acne treatment cleanserSALICYLIC ACIDPhilosophy Inc.e76dfe48-db23-47e9-8f86-640c9c7bc2a42025-12-17WarningsExact identifier
application number: M006
clear days ahead oil-free salicylic acid acne treatment and moisturizerSALICYLIC ACIDPhilosophy Inc.d7895387-100c-4cc4-9c25-0f3b9d0f59372025-12-17WarningsExact identifier
application number: M006
clear days ahead overnight repair salicylic acid acne treatment padsSALICYLIC ACIDPhilosophy Inc.741c6f90-2e32-4700-bb9f-d30329bd3dc32025-12-17WarningsExact identifier
application number: M006
clear days ahead fast-acting salicylic acid acne spot treatmentSALICYLIC ACIDPhilosophya61d0f78-9759-4085-b5e5-577d349be9fd2025-12-17WarningsExact identifier
application number: M006
Stage Fight Acne MaskSULFUR, RESORCINOLBioelements, Inc21ca8de4-28b5-425f-e063-6394a90a33402025-12-17WarningsExact identifier
application number: M006
Spot DefySULFURBioelements, Inc.6f35f950-8d04-4181-a897-5679fde1e2d92025-12-17WarningsExact identifier
application number: M006
BlemFreeSALICYLIC ACIDEquibal, Inc.d6720efc-dbbe-4304-bb31-972b506a08bf2025-12-17WarningsExact identifier
application number: M006
BlemfreeSALICYLIC ACIDEEquibal, Inc.424dba97-0d40-4801-9fec-4b80ab60f9002025-12-17WarningsExact identifier
application number: M006
Renu Laboratories Acne Sulphur LACNE SULFUR LOTIONRenu Laboratories, LLC13de0e4c-b134-41c0-e054-00144ff88e882025-12-16WarningsExact identifier
application number: M006
SUPER SPOT REMOVER ACNE TREATMENTSALICYLIC ACIDORIGINS NATURAL RESOURCES INC.a0aece76-008b-4af3-be39-13156acc73af2025-12-15WarningsExact identifier
application number: M006
DRx Blemish Clarifying MaskSULFURDr. Dennis Gross Skincare7093a8d4-1910-4b23-9d88-d3398db0916a2025-12-15WarningsExact identifier
application number: M006
e.l.f. PLZ Clarify Facial OilSALICYLIC ACIDe.l.f. Cosmetics, Inc.26cde11d-e05e-35a7-e063-6394a90a1fdf2025-12-14WarningsExact identifier
application number: M006
Image Clear Cell Acne Spot TreatmentSALICYLIC ACID ACNE GELSwiss-American CDMO, LLCf1b272ba-683e-4eff-a3ac-a046f547d5e52025-12-11WarningsExact identifier
application number: M006
Dr Mellaxeen SKIN SAVER ACNE RELIEF StickSALICYLIC ACIDLongway Lab Inc.45b85ebb-c00a-61df-e063-6294a90a11bc2025-12-11WarningsExact identifier
application number: M006
Dr.Mellaxeen SKIN SAVER DAILY ACNE ESSENTIALS KitSALICYLIC ACIDLongway Technology(Guangzhou)Co.,Ltd.45b89790-1056-b6a2-e063-6294a90a6f662025-12-11WarningsExact identifier
application number: M006
MULTI-ACTION CLEAR - ACNE CLEARING TREATMENT 2% SALICYLIC ACIDSALICYLIC ACIDStriVectin Operating Company, Inc.f1d93376-4fc2-751f-e053-2a95a90a68882025-12-09WarningsExact identifier
application number: M006
PowerSpot CleanseSULFURBluemercury443ae172-bacd-4122-8d78-d2214bcb02fd2025-12-09WarningsExact identifier
application number: M006
GM COLLIN PURACNESALICYLIC ACIDLaboratoires Dermo-Cosmetik Inc.2619cc3b-5246-4519-94c4-07e0338b273c2025-12-09WarningsExact identifier
application number: M006
Hero Cosmetics Pimple Correct Salicylic Acid Acne TreatmentSALICYLIC ACIDChurch & Dwight Co., Inc.869afe67-edae-4778-b990-08c2313d5aad2025-12-05WarningsExact identifier
application number: M006
XIMONTH Bee Venom All-In-One CreamSALICYLIC ACIDShantou Ximonth Biotechnology Co., Ltd.451e2c76-dd85-7b04-e063-6294a90afad32025-12-04WarningsExact 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