FDA.reportPublic FDA data

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 dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage63433-389-00IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage63433-389-00IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63433-389-00IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage63433-389-00EExcluded after deficient or non-compliant submission was not corrected110d247fa046…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
IngredientStrength
SULFUR6 mg/.2g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
70FD1KFU70Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
199632Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
84d49048-95cf-4f14-9698-c746237fec9dAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63433-389-002022-03-15C16284748780-19d75b9d1-1f0e-f424-e053-dadaa90a57ceDHC Acne Spot Therapy
63433-389-002020-01-31C16284748780-19d75b9d1-1f0e-f424-e053-dadaa90a57ceDHC Acne Spot Therapy

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63433-389-00DHC Acne Spot Therapy15 g in 1 TUBECREAM154

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63433-389DHC ACNE SPOT THERAPY (SULFUR) CREAM [DHC USA INCORPORATED]3Current NDC, Legacy NDC, 1 package rows20241018_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 10 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SUFLUR SPOTandMASK Acne Clearing Treatment MaskSULFURCA-Botana International4d77310a-2441-a17e-e063-6394a90ae68b2026-03-20WarningsExact identifier
application number: M006
Daily Acne Control CleanserBENZOYL PEROXIDEAmazon.com Services LLC2dddc0ef-352a-4973-8402-15aecddcc43f2026-03-20Warnings, Adverse reactionsExact identifier
application number: M006
Saltair Acne BodyspraySALICYLIC ACIDSaltair Body LLC4d7c16a6-9b43-fbe3-e063-6294a90af0512026-03-20WarningsExact identifier
application number: M006
Byoma Acne Clearing Body WashSALICYLIC ACIDByoma Ltd2fffd6a2-1a0e-36d4-e063-6294a90ad1bc2026-03-19WarningsExact identifier
application number: M006
Derm Acne Solution GelSALICYLIC ACIDYantai Aien Biotechnology Co., Ltd.4d6c98ab-801d-63bc-e063-6294a90a20c32026-03-19WarningsExact identifier
application number: M006
Sofie Pavitt Face Reset Benzoyl Peroxide Acne Treatment MaskBENZOYL PEROXIDECosco International, Inc.464c0ed1-ebc4-45b1-80e3-dfe0b76312e32026-03-17WarningsExact identifier
application number: M006
Neutrogena Rapid Clear Stubborn Acne SpotBENZOYL PEROXIDEKenvue Brands LLC5b11b2de-d156-4d6a-8024-0a945661cd9a2026-03-12WarningsExact identifier
application number: M006
Clean and Clear persa-gel 10 Maximum StrengthBENZOYL PEROXIDEKenvue Brands LLCc9642441-4d3a-1128-e053-2995a90aefd12026-03-12WarningsExact identifier
application number: M006
14% Azelaic Acid AcneAZELAIC ACIDGuangdong Bisutang Biotechnology Co., Ltd.4ccaa734-83be-611b-e063-6294a90ab3bf2026-03-11WarningsExact identifier
application number: M006
Body WashSALICYLIC ACIDAmazon.com Services LLCb5d7da95-81ff-4ef9-8b80-2d046cc2a6082026-03-10Warnings, Adverse reactionsExact identifier
application number: M006
Tula Skincare Breakout Star Lightweight Acne MoisturizerSALICYLIC ACIDThe Procter & Gamble Manufacturing Company4bd1d5f5-1b3c-5e82-e063-6394a90a64542026-03-09WarningsExact identifier
application number: M006
natouchSALICYLIC ACIDNatouch LLC4cb2cc1b-1793-b0c4-e063-6294a90a430f2026-03-08WarningsExact identifier
application number: M006
BYT BANGYTONG MILIA REMOVERSALICYLIC ACID 1% MILIA REMOVER LIQUIDShenzhen Jindali Technology Co., Ltd4c5c3368-b3d2-976f-e063-6294a90a70462026-03-06WarningsExact identifier
application number: M006
RoyceDerm Rosacea Relief Cream.SULFUR 1X HPUS 10%RoyceDerm LLC4c3f6332-de46-f107-e063-6294a90ad63f2026-03-04WarningsExact identifier
application number: M006
Medicated Apricot ScrubSALICYLIC ACIDTopco Associates LLC66ccfcb7-6217-4bfb-ac11-4bcbdecb27d82026-03-03Warnings, Adverse reactionsExact identifier
application number: M006
Acne TreatmentBENZOYL PEROXIDEAmazon.com Services LLC08c28255-a223-416e-a2d9-ecb149b0f0512026-03-03Warnings, Adverse reactionsExact identifier
application number: M006
Neutrogena Evenly Clear Acne Gel MoisturizerSALICYLIC ACIDKenvue Brands LLC3f8f344d-a468-8eb3-e063-6394a90a7dd72026-03-02WarningsExact identifier
application number: M006
Acne ScrubSALICYLIC ACIDOld East Main Co.f63d4184-44a2-484f-ae51-ce37e19374a22026-03-02Warnings, Adverse reactionsExact identifier
application number: M006
Acne WashSALICYLIC ACIDOld East Main Co.7bf6f18f-a1ec-460e-afbc-51be1add05b62026-03-02Warnings, Adverse reactionsExact identifier
application number: M006
Advanced DermaClear SerumSALICYLIC ACIDAllure Labs4c10bc9a-52b0-fbf2-e063-6394a90a57802026-03-02WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199632sulfur 3 % Topical CreamPSN84d49048-95cf-4f14-9698-c746237fec9d4
199632sulfur 30 MG/ML Topical CreamSCD84d49048-95cf-4f14-9698-c746237fec9d4
199632sulfur 3 % Topical CreamSY84d49048-95cf-4f14-9698-c746237fec9d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63433-389-006343303890015 g in 1 TUBE (63433-389-00) 15 g2018-01-010000-00-00NoNoCurrent