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 51 of 54 · 1,079 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Differin Acne Clearing Body SALICYLIC ACID Galderma Laboratories, L.P. ce4d1074-5f74-4ad7-9535-2737f5fff24f 2023-12-11 Warnings Exact identifier application number: M006 Vichy Laboratoires Normaderm Phytoaction Acne Control Daily Moisturizer SALICYLIC ACID L'Oreal USA Products Inc b7d0d094-6a5b-4776-9f13-1f8d30542476 2023-12-11 Warnings Exact identifier application number: M006 Vichy Laboratoires Normaderm Phytoaction Deep Cleansing SALICYLIC ACID COSMETIQUE ACTIVE PRODUCTION b61a3f74-a588-47f4-b4a5-c8f97f98d9dd 2023-12-11 Warnings Exact identifier application number: M006 Vichy Laboratoires Normaderm BHA Exfoliating Serum Acne Treatment SALICYLIC ACID L'Oreal USA Products Inc c6f5e9a4-c938-4c44-ace7-a9688b227d59 2023-12-11 Warnings Exact identifier application number: M006 Clarifying Toner SALICYLIC ACID Allure Labs 0c07e6e9-18c1-20da-e063-6294a90aa3c8 2023-12-08 Warnings Exact identifier application number: M006 Acne Advanced Clarifying Hydrator SALICYLIC ACID Eminence Organic Skin Care Ltd. b710cc36-f589-4116-a0a2-c6966ebebbf2 2023-12-08 Warnings Exact identifier application number: M006 Foaming Cleanser SALICYLIC ACID Allure Labs 0bf4c2d8-2fbf-a1c4-e063-6294a90ac130 2023-12-07 Warnings Exact identifier application number: M006 CLEAROGEN 3 BENZOYL PEROXIDE Allure Labs 0bdf9f38-5763-a4d0-e063-6394a90a41dc 2023-12-06 Warnings Exact identifier application number: M006 REPLENIX ACNE 10% WASH PARABEN FREE WITH ALOE BENZOYL PEROXIDE Topiderm, Inc. ea9a32c4-3795-4718-9394-bac69091c732 2023-12-04 Warnings Exact identifier application number: M006 Acne Advanced Treatment System SALICYLIC ACID Eminence Organic Skin Care Ltd. 9acf53a6-10f1-470d-b270-3a0203cf89c0 2023-12-02 Warnings Exact identifier application number: M006 Cetaphil Gentle Clear BPO Acne Cleanser BENZOYL PEROXIDE Galderma Laboratories, L.P. 6397f20f-d69f-47e4-a123-4cc7e1abfcad 2023-11-29 Warnings Exact identifier application number: M006 Acne Fighting Spot with Aloe clear SALICYLIC ACID Zhejiang Ayan Biotech Co.,Ltd. db0054b1-29b9-48fa-8a02-86683bae8134 2023-11-21 Warnings Exact identifier application number: M006 Cetaphil Gentle Clear Clarifying Acne Cleanser SALICYLIC ACID Galderma Laboratories, L.P. 9add83f2-7da6-4cd0-b91b-f6c937a56255 2023-11-20 Warnings Exact identifier application number: M006 Dr. Gross AB Acne Daily Breakout SALICYLIC ACID Topiderm, Inc 79d7f1f6-d08f-4be0-afc1-9ab4338a954d 2023-11-20 Warnings Exact identifier application number: M006 Dr. Dennis Gross Alpha Beta On the Spot Eliminator SALICYLIC ACID Topiderm, Inc e0dccdbc-56fd-4034-b479-f2a2ebde2234 2023-11-16 Warnings Exact identifier application number: M006 Cetaphil Gentle Clear Triple-Action Acne Serum SALICYLIC ACID Galderma Laboratories, L.P. 3e6eb59f-c523-460e-87ed-750b4a8cacac 2023-11-16 Warnings Exact identifier application number: M006 Medicated Wash SALICYLIC ACID Vivier Pharma, Inc. e90ab8b6-6a77-4e02-9d71-45cd7383cb0a 2023-11-14 Warnings Exact identifier application number: M006 GOODBYE ACNE Complete treatment gel SALICYLIC ACID Peter Thomas Roth, LLC 09b88031-f5fe-8ae1-e063-6394a90a8a6a 2023-11-14 Warnings Exact identifier application number: M006 L BRI Pure n Natural Deep Clean Toner SALICYLIC ACID L'BRI HEALTH AND BEAUTY INC 353e948e-da5d-4c15-adcb-77ef978cf05f 2023-11-11 Warnings Exact identifier application number: M006 MD-Acne Body Acne Treatment BENZOYL PEROXIDE MD Algorithms Inc. 97981e9b-d56a-42f6-a75f-647b4732021e 2023-11-11 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