FDA.reportPublic FDA data

Sulfo lo

Product NDC
0316-0118
11-digit product format
003160118
Labeler code
0316
Product ID
0316-0118_4833e6b4-3673-08d5-e063-6394a90aa791
Type
HUMAN OTC DRUG
Nonproprietary name
Sulfur 3% Soap Bar
Dosage form
SOAP
Route
TOPICAL
Labeler
Crown Laboratories
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1965-11-01
Substance
SULFUR
Active strength
30 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
Sulfo lo
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFUR30 mg/g

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
212397Internal RxNorm lookup
248410Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
89577417-76a0-cb04-e053-2995a90a5733Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-02-13Sulfo-Lo Cleansing Bar Soap
2023-02-13Sulfo-Lo Cleansing Bar Soap
2023-01-30Sulfo-Lo Cleansing Bar Soap
2023-01-30Sulfo-Lo Cleansing Bar Soap

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0316-0118-35Sulfo lo99 g in 1 CARTONSOAP996

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0316-0118-35EA - Each0316-0118798cb2da-4fb1-4bf1-aad3-e5053b22282112021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0316-0118SULFO LO (SULFUR 3% SOAP BAR) SOAP [CROWN LABORATORIES]4Current NDC, Legacy NDC, 1 package rows20231122_89577417-76a0-cb04-e053-2995a90a5733.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 13 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oil Free Acne WashSALICYLIC ACID 2%CVS Pharmacy, Inc.7a8225ab-b60a-4978-bdfe-db0b00307ef12026-02-03WarningsExact identifier
application number: M006
Acne TreatmentBENZOYL PEROXIDECVS Pharmacy, Inc.d9fbaeba-cebf-4d02-aa7d-3ee1d2fdc50c2026-02-02Warnings, Adverse reactionsExact identifier
application number: M006
Even and Clear Exfoliating WashSALICYLIC ACIDAmbi Enterprises, LLC499d7616-4677-f6a7-e063-6294a90aeaa22026-01-30WarningsExact identifier
application number: M006
Medicated Apricot ScrubSALICYLIC ACIDRite Aid Corporationfb90b880-07e5-4bda-b907-228a669505552026-01-30Warnings, Adverse reactionsExact identifier
application number: M006
Acne TreatmentBENZOYL PEROXIDERite Aid Corporationa51b7668-1ba1-42cb-b804-4fdf766106952026-01-30Warnings, Adverse reactionsExact identifier
application number: M006
Acne TreatmentSALICYLIC ACIDNatureplex, LLC31b50718-cc60-460d-aad7-b9620970d4112026-01-29WarningsExact identifier
application number: M006
Peace Out Acne CleanserSALICYLIC ACIDPeace Out LLC0a8897b0-cb8f-ba50-e063-6394a90a7f342026-01-29WarningsExact identifier
application number: M006
Peace Out Acne MoisturizerSALICYLIC ACIDPeace Out LLC.18bb4314-0b18-b3bc-e063-6294a90a18542026-01-29WarningsExact identifier
application number: M006
ZITFREE ACNE TREATMENTBENZOYL PEROXIDENatureplex, LLC70c2e3fb-e643-467b-80fd-c40e3c3e95132026-01-29WarningsExact identifier
application number: M006
ProBliva Antibacterial and Acne Body WashANTIBACTERIAL AND ACNE BODY WASHCAVTECH HOLDING LLC496f7a1e-05b6-d434-e063-6394a90afe542026-01-28WarningsExact identifier
application number: M006
Sunscreen SPF50NON NANO ZINC OXIDESBS BILIMSEL BIO COZUMLER SANAYI VE TICARET ANONIM SIRKETI PINAR SUBESIc5d52f13-a649-9579-e053-2a95a90a062c2026-01-27WarningsExact identifier
application number: M006
Viaderma Calm Anti-ItchHYDROCORTISONEVIADERMA DISTRIBUTION INCea281bde-a7a2-47b6-895a-5dc2924972de2026-01-27WarningsExact identifier
application number: M006
Viaderma Clear Acne TreatmentSALICYLIC ACIDVIADERMA DISTRIBUTION INCace405bd-6fe6-4db1-ba1f-9b9861abe6632026-01-27WarningsExact identifier
application number: M006
DHC Acne Spot TherapySULFURDHC USA Incorporated84d49048-95cf-4f14-9698-c746237fec9d2026-01-24WarningsExact identifier
application number: M006
MEDPURA Benzoyl Peroxide Aqueous Base, Acne Treatment GelBENZOYL PEROXIDEAkron Pharma Inc.b7d335d1-3022-4b28-913c-477152a7dad22026-01-23WarningsExact identifier
application number: M006
Skinkure Acne Eraser Spot TreatmentSALICYLIC ACIDSKINKURE, LLC0fc85727-4321-7750-e063-6294a90ad3fe2026-01-23WarningsExact identifier
application number: M006
EmuaidSALICYLIC ACIDSpeer Laboratories, LLCa1486276-30f7-4245-815b-d57edf411cda2026-01-23WarningsExact identifier
application number: M006
Neutrogena Evenly Clear Acne CleanserSALICYLIC ACIDKenvue Brands LLC3e985a61-2aa7-963b-e063-6294a90a7c122026-01-22WarningsExact identifier
application number: M006
Resurfacing acne swipesSALICYLIC ACIDSKIN PS Brands9629fdcb-f3b5-9685-e053-2a95a90a02302026-01-22WarningsExact identifier
application number: M006
PanOxylSALICYLIC ACIDCrown Laboratories48fd0106-4db4-f33a-e063-6294a90a5a0b2026-01-22WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
212397Sulfo-Lo 3 % Medicated Bar SoapPSN89577417-76a0-cb04-e053-2995a90a57336
248410sulfur 3 % Medicated Bar SoapPSN89577417-76a0-cb04-e053-2995a90a57336
212397sulfur 0.03 MG/MG Medicated Bar Soap [Sulfo-Lo]SBD89577417-76a0-cb04-e053-2995a90a57336
248410sulfur 0.03 MG/MG Medicated Bar SoapSCD89577417-76a0-cb04-e053-2995a90a57336
212397Sulfo-Lo 3 % Medicated Bar SoapSY89577417-76a0-cb04-e053-2995a90a57336
248410sulfur 3 % Medicated Bar SoapSY89577417-76a0-cb04-e053-2995a90a57336

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0316-0118-350031601183599 g in 1 CARTON (0316-0118-35) 99 g1965-11-010000-00-00NoNoCurrent