Home NDC 63433-389 DHC Acne Spot Therapy
Product NDC 63433-389
11-digit product format 634330389
Labeler code 63433
Product ID 63433-389_4ae85fb3-936c-45b4-95d9-b3206952cd94
Type HUMAN OTC DRUG
Nonproprietary name Sulfur
Dosage form CREAM
Route TOPICAL
Labeler DHC USA Incorporated
Application M006
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-01-01
Substance SULFUR
Active strength 6 mg/.2g
NDC exclude flag No
Listing certified through 2027-12-31
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 · 8 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 2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 63433-389-00 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 63433-389-00 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 63433-389-00 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 63433-389-00 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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 DHC Acne Spot Therapy
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SULFUR 6 mg/.2g
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 199632 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63433-389-00 DHC Acne Spot Therapy 15 g in 1 TUBE CREAM 15 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63433-389 DHC ACNE SPOT THERAPY (SULFUR) CREAM [DHC USA INCORPORATED] 3 Current NDC, Legacy NDC, 1 package rows 20241018_84d49048-95cf-4f14-9698-c746237fec9d.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 27 of 55 · 1,088 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join NAELI Exfoliator AHA BHA Face Cleanser SALICYLIC ACID ALLI LLC e2a613c3-34f4-477e-99e6-67bcc7c117c4 2025-06-23 Warnings Exact identifier application number: M006 Acne Treatment Cream ACNE TREATMENT CREAM Guangzhou Yapeng Refinement Chemical Co., Ltd. 37fc7d7f-da18-ac40-e063-6394a90abb5d 2025-06-20 Warnings Exact identifier application number: M006 Blemish Correcting Serum SALICYLIC ACID Topiderm, Inc. 84029bb8-a840-4b68-9a07-683886733229 2025-06-17 Warnings Exact identifier application number: M006 ACNE TREATMENT COTTON PADS ACNE TREATMENT COTTON PADS Guangzhou Yapeng Refinement Chemical Co., Ltd. 37ad7cd7-92df-82d9-e063-6294a90a0f04 2025-06-16 Warnings Exact identifier application number: M006 La Roche Posay Laboratoire Dermatologique Effaclar AZ Acne Treatment SALICYLIC ACID COSMETIQUE ACTIVE PRODUCTION 75e15ed6-e871-4dde-b7fc-145054626fa9 2025-06-12 Warnings Exact identifier application number: M006 La Roche Posay Laboratoire Dermatologique Effaclar AZ Acne Treatment SALICYLIC ACID L'Oreal USA Products Inc 2ac3a8c0-e0ed-435f-90fb-72c7a55a0673 2025-06-12 Warnings Exact identifier application number: M006 Margarite Zinc Cream ZINC CREAM Renu Laboratories, LLC 3ca3b7d8-702a-036b-e054-00144ff8d46c 2025-06-10 Warnings Exact identifier application number: M006 Facial Cleansing Wipes FACIAL CLEANSING WIPES Shenzhen Shierjie Biological Engineering Co., LTD 36f7677a-ec73-e677-e063-6294a90ad480 2025-06-07 Warnings Exact identifier application number: M006 La Roche Posay Laboratoire Dermatologique Effaclar Duo Plus M Multi Target Acne Treatment SALICYLIC ACID L'Oreal USA Products Inc b36837e3-ea1c-41db-b52c-417510089529 2025-06-05 Warnings Exact identifier application number: M006 VENROCK SALICYLIC ACID Guangzhou Oupeng Cosmetics Co., Ltd. 349ae621-c832-128c-e063-6294a90a284d 2025-06-05 Warnings Exact identifier application number: M006 La Roche Posay Laboratoire Dermatologique Effaclar Duo Plus M Multi Target Acne Treatment SALICYLIC ACID COSMETIQUE ACTIVE PRODUCTION bc9fffbc-c176-4d89-b1c6-294a8439a930 2025-06-05 Warnings Exact identifier application number: M006 Neutrogena Stubborn Acne AM Treatment BENZOYL PEROXIDE Kenvue Brands LLC d6e05b11-8c5f-490d-a5d8-116dcc895cb8 2025-06-04 Warnings Exact identifier application number: M006 TULA SKINCARE BREAKOUT BREAKTHROUGH ACNE TONER PADS SALICYLIC ACID The Procter & Gamble Manufacturing Company 36ada73d-cfc5-d4a4-e063-6294a90a7c73 2025-06-03 Warnings Exact identifier application number: M006 Psoriasis Body Wash COLLOIDAL OATMEAL Rida LLC 4b2bba1b-7e7b-4397-9eb4-d94c44b98314 2025-06-03 Warnings Exact identifier application number: M006 Gly-Sal 10-2 SALICYLIC ACID Topiderm, Inc. 4058327e-2764-4df0-9d5d-7cda72d9ca41 2025-06-02 Warnings Exact identifier application number: M006 Dissolvable Microneedle Blemish Patches SALICYLIC ACID Advaccine Biopharmaceuticals Suzhou Co., Ltd 3640d29e-7e4c-b3be-e063-6394a90a0d9e 2025-05-29 Warnings Exact identifier application number: M006 Neutrogena Oil Free Acne Stress Control Triple Action Toner SALICYLIC ACID Kenvue Brands LLC 36412939-97bc-6cb1-e063-6294a90aef48 2025-05-29 Warnings Exact identifier application number: M006 Tula Skincare Clear It Up Acne Clearing and Tone Correcting Gel SALICYLIC ACID The Procter & Gamble Manufacturing Company 364a96fb-67fe-eeb7-e063-6394a90aa60c 2025-05-29 Warnings Exact identifier application number: M006 Psoriasis Scalp Treatment SALICYLIC ACID Rida LLC 14ab77e7-86b0-49d3-8efa-8a80c5a24d74 2025-05-28 Warnings Exact identifier application number: M006 Aveeno Positively Radiant Clear Complexion Foaming Cleanser SALICYLIC ACID Kenvue Brands LLC ec136786-9d46-a022-e053-2a95a90a0752 2025-05-26 Warnings Exact identifier application number: M006
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 63433-389-00 63433038900 15 g in 1 TUBE (63433-389-00) 15 g 2018-01-01 0000-00-00 No No Current