Home NDC 76348-450 Renu Laboratories Acne Sulphur L
Product NDC 76348-450
11-digit product format 763480450
Labeler code 76348
Product ID 76348-450_4616a187-4faa-181d-e063-6294a90ae910
Type HUMAN OTC DRUG
Nonproprietary name Acne Sulfur Lotion
Dosage form SUSPENSION
Route TOPICAL
Labeler Renu Laboratories, LLC
Application M006
Marketing category OTC MONOGRAPH DRUG
Marketing start 2015-04-16
Substance SULFUR
Active strength 1.4 g/14g
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 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 76348-450-02 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 76348-450-02 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 76348-450-02 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 76348-450-02 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 76348-450-02 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 76348-450-02 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 76348-450-02 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 76348-450-02 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 76348-450-02 U Excluded because listing certification expired 0efc9e666f02…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 Renu Laboratories Acne Sulphur L
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SULFUR 1.4 g/14g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 70FD1KFU70 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 240725 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 76348-450-02 Renu Laboratories Acne Sulphur L 56 g in 1 BOTTLE, GLASS SUSPENSION 56 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SULFUR ACTIVE INGREDIENT 70FD1KFU70 RENU LABORATORIES ACNE SULPHUR L (ACNE SULFUR LOTION) SUSPENSION [RENU LABORATORIES, INC.] 2 SULFUR ACTIVE MOIETY 70FD1KFU70 RENU LABORATORIES ACNE SULPHUR L (ACNE SULFUR LOTION) SUSPENSION [RENU LABORATORIES, INC.] 2 CAMPHOR (SYNTHETIC) INACTIVE INGREDIENT 5TJD82A1ET RENU LABORATORIES ACNE SULPHUR L (ACNE SULFUR LOTION) SUSPENSION [RENU LABORATORIES, INC.] 2 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 RENU LABORATORIES ACNE SULPHUR L (ACNE SULFUR LOTION) SUSPENSION [RENU LABORATORIES, INC.] 2 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 RENU LABORATORIES ACNE SULPHUR L (ACNE SULFUR LOTION) SUSPENSION [RENU LABORATORIES, INC.] 2 MAGNESIUM ALUMINUM SILICATE INACTIVE INGREDIENT 6M3P64V0NC RENU LABORATORIES ACNE SULPHUR L (ACNE SULFUR LOTION) SUSPENSION [RENU LABORATORIES, INC.] 2 SALICYLIC ACID INACTIVE INGREDIENT O414PZ4LPZ RENU LABORATORIES ACNE SULPHUR L (ACNE SULFUR LOTION) SUSPENSION [RENU LABORATORIES, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R RENU LABORATORIES ACNE SULPHUR L (ACNE SULFUR LOTION) SUSPENSION [RENU LABORATORIES, INC.] 2 ZINC OXIDE INACTIVE INGREDIENT SOI2LOH54Z RENU LABORATORIES ACNE SULPHUR L (ACNE SULFUR LOTION) SUSPENSION [RENU LABORATORIES, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76348-450 RENU LABORATORIES ACNE SULPHUR L (ACNE SULFUR LOTION) SUSPENSION [RENU LABORATORIES, INC.] 5 Current NDC, Legacy NDC, 1 package rows 20220118_13de0e4c-b134-41c0-e054-00144ff88e88.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 43 of 55 · 1,088 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 76348-450-02 76348045002 56 g in 1 BOTTLE, GLASS (76348-450-02) 56 g 2015-04-16 0000-00-00 No No Current