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 15 of 55 · 1,088 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Peace Out Acne Serum SALICYLIC ACID Peace Out LLC. 7cd68513-0470-4409-82d0-619c97e69ff4 2026-01-14 Warnings Exact identifier application number: M006 MEDPURA Benzoyl Peroxide BENZOYL PEROXIDE Akron Pharma Inc. 1b051efe-054b-42a0-915a-b87885bd3c54 2026-01-13 Warnings Exact identifier application number: M006 END-ZIT SULFUR ABBE Laboratories, Inc. afed5e8e-324c-44c6-abf6-72938376a4b2 2026-01-13 Warnings Exact identifier application number: M006 Neutrogena Oil Free Acne Wash SALICYLIC ACID Kenvue Brands LLC c4775032-9723-4208-8a42-145f2b4da1c8 2026-01-12 Warnings Exact identifier application number: M006 BHA CLEANSER 2% SALICYLIC ACID Skinfix, Inc. ceccb599-ff9e-fc87-e053-2a95a90a411a 2026-01-12 Warnings Exact identifier application number: M006 ACNE SPOT TREATMENT 2% BHA SALICYLIC ACID Skinfix, Inc. ceccea68-07d8-0903-e053-2995a90ab2b7 2026-01-12 Warnings Exact identifier application number: M006 Sulfo lo SULFUR 3% SOAP BAR Crown Laboratories 89577417-76a0-cb04-e053-2995a90a5733 2026-01-12 Warnings Exact identifier application number: M006 PanOxyl BENZOYL PEROXIDE Crown Laboratories 1660f219-e789-91f1-e063-6294a90a7664 2026-01-12 Warnings Exact identifier application number: M006 PanOxyl BENZOYL PEROXIDE Crown Laboratories ff09cbab-304b-4da9-e053-6394a90ae600 2026-01-12 Warnings Exact identifier application number: M006 PanOxyl Clarifying Exfoliant SALICYLIC ACID Crown Laboratories, Inc. faa6576c-2af2-d86b-e053-6294a90ada2d 2026-01-12 Warnings Exact identifier application number: M006 PanOxyl BENZOYL PEROXIDE Crown Laboratories 7b301b94-3cc8-b05b-e053-2991aa0aa561 2026-01-12 Warnings Exact identifier application number: M006 PanOxyl Acne Gel Wash SALICYLIC ACID Crown Laboratories, Inc. 39712bb8-3d4e-29b3-e063-6394a90a95b8 2026-01-12 Warnings Exact identifier application number: M006 Proactiv Clean Mineral Acne Cleanser SULFUR Alchemee, LLC 380d0f8f-8d31-41b9-9d5f-8a35f7f81b5b 2026-01-07 Warnings Exact identifier application number: M006 Proactiv Clean Acne Clearing Hydrator SALICYLIC ACID Alchemee, LLC 33ac397c-55af-4a50-b5ce-80f8a8801581 2026-01-07 Warnings Exact identifier application number: M006 Proactiv CLEAR ZONE BODY PADS SALICYLIC ACID Alchemee, LLC cf9e5536-08f6-4bbd-9e09-2e9a0c768ed9 2026-01-07 Warnings Exact identifier application number: M006 Proactiv Plus Complexion Perfecting Hydrator SALICYLIC ACID Alchemee, LLC c9b91b61-738e-474e-927f-0806264c739e 2026-01-07 Warnings Exact identifier application number: M006 Proactiv plus Pore Targeting Treatment BENZOYL PEROXIDE Alchemee, LLC 12f2eeab-d258-4eb1-8fe2-784c51c2e4cc 2026-01-07 Warnings Exact identifier application number: M006 Proactiv Plus Retexturizing Toner SALICYLIC ACID Alchemee, LLC 7c211ff7-920f-407b-ad8d-60d14803b857 2026-01-07 Warnings Exact identifier application number: M006 Proactiv Clarifying Night SALICYLIC ACID Alchemee, LLC 8b81b4e5-f2fc-45a1-923a-7c326529d68b 2026-01-07 Warnings Exact identifier application number: M006 Proactiv Emergency Blemish Relief BENZOYL PEROXIDE Alchemee, LLC 72bb45ca-3f68-47be-928e-755cc66419d9 2026-01-07 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