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 54 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Artistry Studio Done With Zit Acne Treatment Clearing GelSALICYLIC ACIDAccess Business Group LLC7a9bb4a0-c463-44e8-90a3-12bd58829f9d2023-10-21WarningsExact identifier
application number: M006
PERSISTENT BODY ACNE WASH 8.5OZSALICYLIC ACIDChina Ningbo Shangge Cosmetics Technology Corp.074079cd-866d-0af0-e063-6394a90a72142023-10-09WarningsExact identifier
application number: M006
Skin Laundry. Clean Slate Exfoliating 2 Salicylic Acid Treatment Gel Cleanser Cleanse ExfoliateSALICYLIC ACIDSkin Laundry Holdings, Inc.07100fe5-3884-0948-e063-6294a90a6ec72023-10-06WarningsExact identifier
application number: M006
NAS PORE REFINING SCRUBSALICYLIC ACIDBURT'S BEES, INC.bc2c6b1e-999c-91a7-e053-2a95a90a9d1a2023-10-05WarningsExact identifier
application number: M006
NAS Targeted Spot TreatmentSALICYLIC ACIDBurt's Beesbc193e1f-c2bd-6415-e053-2995a90ae6eb2023-10-05WarningsExact identifier
application number: M006
ACNE AND LINE CORRECTING SERUMSALICYLIC ACIDCLINIQUE LABORATORIES LLCb03bdef4-a099-4543-8673-85466bd649612023-10-05WarningsExact identifier
application number: M006
SPOT ACNE TREATMENT 0.75OZBENZOYL PEROXIDERejoice International Corp.06de40a2-45bf-bf4b-e063-6294a90a586c2023-10-04WarningsExact identifier
application number: M006
PERSISTENT BODY ACNE WASH 8.5OZSALICYLIC ACIDRejoice International Corp.06df07f7-e4c5-ccef-e063-6394a90a9f3c2023-10-04WarningsExact identifier
application number: M006
SPOT ACNE TREATMENT 0.75OZBENZOYL PEROXIDEChina Ningbo Shangge Cosmetics Technology Corp.06e07266-6483-e7ef-e063-6294a90a93952023-10-04WarningsExact identifier
application number: M006
Acne ControlCREAMWalgreenfc60cccb-405b-e49e-e053-6394a90a5a122023-09-11WarningsExact identifier
application number: M006
AnubisMedAZELAIC ACID, SALICYLIC ACIDANUBIS COSMETICS SLebf3153d-30f5-54e4-e053-2995a90a74b12023-09-05WarningsExact identifier
application number: M006
AnubisMedGLYCOLIC ACID, CITRIC ACID, LACTIC ACID, KOJIC ACIDANUBIS COSMETICS SLeca95dde-cb57-2ab6-e053-2995a90af84f2023-09-05WarningsExact identifier
application number: M006
Anubis BarcelonaPEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ALLANTOINANUBIS COSMETICS SLeb9244ea-6102-3cbe-e053-2a95a90ab8f62023-09-01WarningsExact identifier
application number: M006
Anubis Barcelona Regul OilPROPYLENE GLYCOL, PANTHENOL, THIAMINE HCLANUBIS COSMETICS SLeb8e5beb-4452-58c2-e053-2a95a90a66e02023-09-01WarningsExact identifier
application number: M006
Anubis Barcelona Regul OilCETEARYL ETHYLHEXANOATE, PROPYLENE GLYCOL, GLYCERYL STEARATE SEANUBIS COSMETICS SLeb68c3ab-7835-1a1c-e053-2995a90a0d662023-09-01WarningsExact identifier
application number: M006
Anubis Barcelona Regul OIlPEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ARCTIUM MAJUS ROOT EXTRACTANUBIS COSMETICS SLeb905bd0-c600-b8b2-e053-2995a90ad2592023-09-01WarningsExact identifier
application number: M006
Anubis Barcelona Regul OilPROPYLENE GLYCOL, GLYCERYL STEARATE SE, HUMULUS LUPULUS (HOPS) CONE EXTRACTANUBIS COSMETICS SLeb7c418b-8bee-26a3-e053-2a95a90a4e962023-09-01WarningsExact identifier
application number: M006
ACNE CLEANSINGSALICYLIC ACIDCLINIQUE LABORATORIES LLC7bae5802-cf51-4b41-9d7c-d72f1eb4c4af2023-08-30WarningsExact identifier
application number: M006
Gly-Sal 2-2 PadsSALICYLIC ACIDTopiderm, Inc.a92a9ffb-5c5b-43a4-b669-04667324920b2023-02-16WarningsExact identifier
application number: M006
Derma E Acne Clarifying MaskSULFURderma e55df8fb4-abc3-43fe-b89b-6e7d638b27a62023-02-14WarningsExact 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