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 53 of 54 · 1,079 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join HUMANE ACNE WASH BENZOYL PEROXIDE Apprendista, LLC 1d25fb25-a3d2-4c6b-a975-be7b90b70265 2023-11-05 Warnings Exact identifier application number: M006 VIE NATURELLE ACNE BODY BENZOYL PEROXIDE TNT PRO SERIES 0278251d-bcf1-4177-8a57-163bd0f2df00 2023-11-05 Warnings Exact identifier application number: M006 enfuselle Acne Clarifying SALICYLIC ACID Shaklee Corporation dd429a9b-5c2d-4310-8506-6487b02e3880 2023-11-03 Warnings Exact identifier application number: M006 Peach and Lily Peaches Slices Acne Exfoliating toner SALICYLIC ACID Peach & Lily Inc. ba70ed1c-83cb-5eaa-e053-2a95a90a92cc 2023-10-28 Warnings Exact identifier application number: M006 Peach and Lily Peaches Slices Acne Clarifying Cleanser SALICYLIC ACID Peach & Lily, Inc. ba70f2b9-7a34-065c-e053-2a95a90a6eb2 2023-10-28 Warnings Exact identifier application number: M006 Peach and Lily Peaches Slices Acne Oil Acne Free Moisturizer SALICYLIC ACID Peach & Lily, Inc. ba70e7cf-af86-6a7f-e053-2995a90af962 2023-10-28 Warnings Exact identifier application number: M006 Modesa Acne Treatment BENZOYL PEROXIDE Zhejiang Jingwei Pharmaceutic Al Co., Ltd. dbfe8b9e-e343-4ed5-bd81-01b27b4aa912 2023-10-27 Warnings Exact identifier application number: M006 Acne Treatment BENZOYL PEROXIDE Vivier Pharma, Inc. b4844539-bdd2-42a6-b946-6028de4f3cf1 2023-10-27 Warnings Exact identifier application number: M006 Acne Treatment System BENZOYL PEROXIDE, SALICYLIC ACID Vivier Pharma, Inc. d39ee6a2-5d65-4198-82d9-deb83471f312 2023-10-27 Warnings Exact identifier application number: M006 Equate Beauty Quick Action Pads Salicylic Acid Acne Treatment SALICYLIC ACID Bath Concept Cosmetics (Dongguan) Co., Ltd c94e85a7-b799-b70d-e053-2a95a90aaee2 2023-10-26 Warnings Exact identifier application number: M006 ARTISTRY STUDiO Rose All Day Anti Acne Toner Pore Refresher SALICYLIC ACID Access Business Group LLC a9e26804-7989-41d2-8506-c4b65ca385b7 2023-10-21 Warnings Exact identifier application number: M006 Artistry Studio Done With Zit Acne Treatment Clearing Gel SALICYLIC ACID Access Business Group LLC 7a9bb4a0-c463-44e8-90a3-12bd58829f9d 2023-10-21 Warnings Exact identifier application number: M006 PERSISTENT BODY ACNE WASH 8.5OZ SALICYLIC ACID China Ningbo Shangge Cosmetics Technology Corp. 074079cd-866d-0af0-e063-6394a90a7214 2023-10-09 Warnings Exact identifier application number: M006 Skin Laundry. Clean Slate Exfoliating 2 Salicylic Acid Treatment Gel Cleanser Cleanse Exfoliate SALICYLIC ACID Skin Laundry Holdings, Inc. 07100fe5-3884-0948-e063-6294a90a6ec7 2023-10-06 Warnings Exact identifier application number: M006 NAS PORE REFINING SCRUB SALICYLIC ACID BURT'S BEES, INC. bc2c6b1e-999c-91a7-e053-2a95a90a9d1a 2023-10-05 Warnings Exact identifier application number: M006 NAS Targeted Spot Treatment SALICYLIC ACID Burt's Bees bc193e1f-c2bd-6415-e053-2995a90ae6eb 2023-10-05 Warnings Exact identifier application number: M006 ACNE AND LINE CORRECTING SERUM SALICYLIC ACID CLINIQUE LABORATORIES LLC b03bdef4-a099-4543-8673-85466bd64961 2023-10-05 Warnings Exact identifier application number: M006 SPOT ACNE TREATMENT 0.75OZ BENZOYL PEROXIDE Rejoice International Corp. 06de40a2-45bf-bf4b-e063-6294a90a586c 2023-10-04 Warnings Exact identifier application number: M006 PERSISTENT BODY ACNE WASH 8.5OZ SALICYLIC ACID Rejoice International Corp. 06df07f7-e4c5-ccef-e063-6394a90a9f3c 2023-10-04 Warnings Exact identifier application number: M006 SPOT ACNE TREATMENT 0.75OZ BENZOYL PEROXIDE China Ningbo Shangge Cosmetics Technology Corp. 06e07266-6483-e7ef-e063-6294a90a9395 2023-10-04 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