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 45 of 55 · 1,088 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join amazon basics step 1 cleanser Acne treatment BENZOYL PEROXIDE AMAZON.COM SERVICES LLC 23a060f0-d379-4370-9a79-ca6e854419b4 2024-08-26 Warnings Exact identifier application number: M006 SEYTU Spot SALICYLIC ACID Omnilife USA, Inc. 68252aa0-36cd-4380-8898-16a5e4731866 2024-08-23 Warnings Exact identifier application number: M006 Peach Slices 3 Step Acne Starter Kit SALICYLIC ACID Peach & Lily, Inc 0c8860ca-5376-4e98-a7a9-4668dff4f0aa 2024-08-14 Warnings Exact identifier application number: M006 PHARMA CLEAR CLEANSER SALICYLIC ACID PHARMAGEL INTERNATIONAL INC d2c39d80-5ccd-43a8-a8bf-eba502bfdbf1 2024-08-13 Warnings Exact identifier application number: M006 PHARMA CLEAR MOISTURIZER SALICYLIC ACID PHARMAGEL INTERNATIONAL INC c4c08475-bafa-4bb1-92a5-e94e60086264 2024-08-13 Warnings Exact identifier application number: M006 PHARMA CLEAR ACNE TREATMENT SALICYLIC ACID PHARMAGEL INTERNATIONAL INC 6d94f911-d751-45e4-b24d-8d85c6a3cefb 2024-08-13 Warnings Exact identifier application number: M006 Anti-Everything Face Serum SALICYLIC ACID SERUM Bentley laboratories, llC 8330e61c-50ec-44a5-91d9-a97e5a9d0388 2024-08-05 Warnings Exact identifier application number: M006 Anti-Everything Face Moisturizer SALICYLIC ACID CREAM Bentley Laboratories, LLC 36cb28f2-2620-4b88-811f-a2d6c1e22e79 2024-08-05 Warnings Exact identifier application number: M006 Tucks Medicated Cooling Pads WITCH HAZEL Blistex Inc 1eb3c742-7104-7b47-e063-6394a90a84ba 2024-08-02 Warnings Exact identifier application number: M006 Replenix Gly-Sal 10-2 cleanser SALICYLIC ACID Topiderm, Inc. 00d1f8af-88de-4a14-80ec-5ee9fd38b191 2024-08-02 Warnings Exact identifier application number: M006 AL0076001 Alba Botanica Acnedote Deep Pore Wash SALICYLIC ACID The Hain Celestial Group, Inc. 6157c9c6-f252-5b49-e053-2991aa0ad8ed 2024-07-31 Warnings Exact identifier application number: M006 AL00761 Alba Botanica Acnedote Face and Body Scrub SALICYLIC ACID The Hain Celestial Group, Inc. c55efca6-5a5b-134b-e053-2a95a90a8245 2024-07-31 Warnings Exact identifier application number: M006 Gly-Sal 5-2 SALICYLIC ACID Topiderm, Inc. a75e4cee-678f-4e44-9e5e-bafae1c23f9b 2024-07-31 Warnings Exact identifier application number: M006 Face Reality Advanced Acne Med BENZOYL PEROXIDE Face Reality e1eb8496-0611-4dbc-befb-fb43ec164433 2024-07-26 Warnings Exact identifier application number: M006 Face Reality 5% Advanced Acne Med BENZOYL PEROXIDE Face Reality 0e52972d-b4d9-43f8-8dbb-2eec0782e0f7 2024-07-26 Warnings Exact identifier application number: M006 Face Reality 10% Advanced Acne Med BENZOYL PEROXIDE Face Reality a214ea15-6346-4729-ba84-fbc842faf92a 2024-07-26 Warnings Exact identifier application number: M006 Replenix Gly-Sal 2-2 SALICYLIC ACID Topiderm, Inc. 6c6bbedc-e2ee-46a0-8800-e356bdd262b0 2024-07-25 Warnings Exact identifier application number: M006 Thayers Since 1847 Natural Remedies Double Action Acne Serum SALICYLIC ACID L'Oreal USA Products Inc f9daadf9-a9d3-4f2d-af07-5f0b70f7803f 2024-07-17 Warnings Exact identifier application number: M006 BLEMISH DOTS - RETINOL (10 PATCHES) SALICYLIC ACID 0.5% Ganzhou Olivee Cosmetic Co., Ltd. c7164d75-75e7-494a-9595-028ecbf26276 2024-07-14 Warnings Exact identifier application number: M006 BLEMISH DOTS - CHARCOAL (10 PATCHES) SALICYLIC ACID 0.5% Ganzhou Olivee Cosmetic Co., Ltd. 286f642f-7359-41b9-9daf-e866a87fbefa 2024-07-14 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