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 11 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lancome Paris Clarifique BX-Interceptor Topical Acne Clearing TreatmentSALICYLIC ACIDSICOS ET CIE6e366dc4-288a-47b1-ab72-8ed3aa6aea222026-03-02WarningsExact identifier
application number: M006
Lancome Paris Clarifique BX-Interceptor Topical Acne Clearing TreatmentSALICYLIC ACIDLOreal USA Products Incc5ce4ec6-176f-4bb0-96f0-6817e53c14682026-03-02WarningsExact identifier
application number: M006
FOLUPIA MILIA REMOVERSALICYLIC ACID 1% MILIA REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4bca1a8b-2df4-47b1-e063-6394a90a33ff2026-02-27WarningsExact identifier
application number: M006
Medicated Apricot ScrubSALICYLIC ACIDWalmart Inc.56e29d46-a29d-4192-9fdf-58dbcb843d442026-02-27WarningsExact identifier
application number: M006
Acne TreatmentBENZOYL PEROXIDEWalmart Inc.950edb4e-fbba-41e3-9ec5-973806e555e72026-02-27Warnings, Adverse reactionsExact identifier
application number: M006
Body WashSALICYLIC ACIDWalmart Inc.c31a5629-66c3-47a7-96ea-9987b2be82af2026-02-27Warnings, Adverse reactionsExact identifier
application number: M006
Acne Control CleanserSALICYLIC ACIDWalmart Inc.2df52d35-dbb6-1d35-e063-6394a90ae1102026-02-27Warnings, Adverse reactionsExact identifier
application number: M006
Quick ActionSALICYLIC ACIDWalmart Inc.00025ea5-d15f-49d2-a52a-6c1bd8c6a0332026-02-27Warnings, Adverse reactionsExact identifier
application number: M006
Oil Free Acne WashSALICYLIC ACID 2%Walmart Inc.31e49de0-0806-d18b-e063-6294a90ae47d2026-02-27Warnings, Adverse reactionsExact identifier
application number: M006
ACNE SOLUTIONS SPOT HEALING ACNE MEDICATIONSALICYLIC ACIDCLINIQUE LABORATORIES LLCc09ee4f6-b8f9-4d20-982a-fb490830bd342026-02-26WarningsExact identifier
application number: M006
Acne TreatmentBENZOYL PEROXIDEThe Kroger Co.a6526d73-4094-45b7-97f0-561dd10d61e22026-02-26Warnings, Adverse reactionsExact identifier
application number: M006
Oil Free Acne WashSALICYLIC ACID 2%Meijer, Inc.29a62723-a58d-4912-bdab-b2fa1fac27b42026-02-24Warnings, Adverse reactionsExact identifier
application number: M006
Medicated Apricot ScrubSALICYLIC ACIDMeijer, Inc.3aeb4f0b-a8f7-4ed7-b320-45e5ba0c81752026-02-19Warnings, Adverse reactionsExact identifier
application number: M006
Acne CleanserBENZOYL PEROXIDEMeijer, Inc.932ee049-ab3d-4839-a655-772e5594f6e12026-02-19Warnings, Adverse reactionsExact identifier
application number: M006
PHARMA CLEAR SPOT TREATMENTSALICYLIC ACIDPHARMAGEL INTERNATIONAL INC24736409-b500-4aae-857e-1f4fb1760a152026-02-19WarningsExact identifier
application number: M006
Acne ScrubSALICYLIC ACIDUnited Natural Foods, Inc. dba UNFI1a4df18d-8128-4846-80bc-262ba1a2aeca2026-02-17Warnings, Adverse reactionsExact identifier
application number: M006
Oil Free Acne WashSALICYLIC ACID 2%United Natural Foods, Inc. dba UNFIc489c818-d69a-4011-9c37-60c8c5b9522a2026-02-17Warnings, Adverse reactionsExact identifier
application number: M006
Medicated Apricot ScrubSALICYLIC ACIDUnited Natural Foods, Inc. dba UNFI677c19eb-780b-479b-ab1d-df249e0af6ea2026-02-16Warnings, Adverse reactionsExact identifier
application number: M006
PoreFectSALICYLIC ACIDOur-Science Inc.4afe4115-cdf0-6dd3-e063-6394a90a24532026-02-16WarningsExact identifier
application number: M006
iShancare Folliculitis CreamFOLLICULITIS CREAMShenzhen Ishan Technology Co., Ltd0c85c8e9-f50f-1b72-e063-6394a90a88c42026-02-13WarningsExact 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