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 51 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MILANI ERASE BASE BLEMISH CONTROL PRIMER Salicylic AcidSALICYLIC ACIDNew Milani Group, LLCc2d43609-8a7a-4e54-8e8c-66115948dba22023-12-12WarningsExact identifier
application number: M006
Differin Daily Deep Cleanser with BPOBENZOYL PEROXIDEGalderma Laboratories, L.P.192b231b-51f1-457c-9a82-ef75671c0d342023-12-11WarningsExact identifier
application number: M006
SkinCeuticals Silymarin CF Acne TreatmentSALICYLIC ACIDL'Oreal USA Products Incaa439d77-7ba5-4699-8e8b-3bba35f5094d2023-12-11WarningsExact identifier
application number: M006
Vichy Laboratoires Normaderm Acne Control MoisturizerSALICYLIC ACIDCOSMETIQUE ACTIVE PRODUCTION04df2f5d-77f0-4553-9d8c-3f10628736ae2023-12-11WarningsExact identifier
application number: M006
Vichy Laboratoires Normaderm Acne Control Daily MoisturizerSALICYLIC ACIDL'Oreal USA Products Inc4acae53c-3250-4703-83ac-f158562926c62023-12-11WarningsExact identifier
application number: M006
Differin Acne Clearing Body ScrubSALICYLIC ACIDGalderma Laboratories, L.P.b1e9f483-80ad-49f1-974e-4732bacd96392023-12-11WarningsExact identifier
application number: M006
Vichy Laboratoires Normaderm BHA Exfoliating Acne TreatmentSALICYLIC ACIDCOSMETIQUE ACTIVE PRODUCTIONa2369870-cf81-4ebd-a354-858212d67d0e2023-12-11WarningsExact identifier
application number: M006
Vichy Laboratoires Normaderm Phytoaction Daily Deep CleansingSALICYLIC ACIDL'Oreal USA Products Inc0db3a8cb-7691-4772-9f7d-15de66098e2e2023-12-11WarningsExact identifier
application number: M006
Differin Acne Clearing Body WashSALICYLIC ACIDGalderma Laboratories, L.P.b280351f-02d4-4456-85b5-905e835968482023-12-11WarningsExact identifier
application number: M006
Differin Acne Clearing BodySALICYLIC ACIDGalderma Laboratories, L.P.ce4d1074-5f74-4ad7-9535-2737f5fff24f2023-12-11WarningsExact identifier
application number: M006
Vichy Laboratoires Normaderm Phytoaction Acne Control Daily MoisturizerSALICYLIC ACIDL'Oreal USA Products Incb7d0d094-6a5b-4776-9f13-1f8d305424762023-12-11WarningsExact identifier
application number: M006
Vichy Laboratoires Normaderm Phytoaction Deep CleansingSALICYLIC ACIDCOSMETIQUE ACTIVE PRODUCTIONb61a3f74-a588-47f4-b4a5-c8f97f98d9dd2023-12-11WarningsExact identifier
application number: M006
Vichy Laboratoires Normaderm BHA Exfoliating Serum Acne TreatmentSALICYLIC ACIDL'Oreal USA Products Incc6f5e9a4-c938-4c44-ace7-a9688b227d592023-12-11WarningsExact identifier
application number: M006
Clarifying TonerSALICYLIC ACIDAllure Labs0c07e6e9-18c1-20da-e063-6294a90aa3c82023-12-08WarningsExact identifier
application number: M006
Acne Advanced Clarifying HydratorSALICYLIC ACIDEminence Organic Skin Care Ltd.b710cc36-f589-4116-a0a2-c6966ebebbf22023-12-08WarningsExact identifier
application number: M006
Foaming CleanserSALICYLIC ACIDAllure Labs0bf4c2d8-2fbf-a1c4-e063-6294a90ac1302023-12-07WarningsExact identifier
application number: M006
CLEAROGEN 3BENZOYL PEROXIDEAllure Labs0bdf9f38-5763-a4d0-e063-6394a90a41dc2023-12-06WarningsExact identifier
application number: M006
REPLENIX ACNE 10% WASH PARABEN FREE WITH ALOEBENZOYL PEROXIDETopiderm, Inc.ea9a32c4-3795-4718-9394-bac69091c7322023-12-04WarningsExact identifier
application number: M006
Acne Advanced Treatment SystemSALICYLIC ACIDEminence Organic Skin Care Ltd.9acf53a6-10f1-470d-b270-3a0203cf89c02023-12-02WarningsExact identifier
application number: M006
Cetaphil Gentle Clear BPO Acne CleanserBENZOYL PEROXIDEGalderma Laboratories, L.P.6397f20f-d69f-47e4-a123-4cc7e1abfcad2023-11-29WarningsExact 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