FDA.reportPublic FDA data

Wentworth Alcohol Free

Product NDC
11527-735
11-digit product format
115270735
Labeler code
11527
Product ID
11527-735_b2ef98a2-03e1-4db5-a35e-9820d5fddf6e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
MOUTHWASH
Route
DENTAL
Labeler
Sheffield Pharmaceuticals LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2021-04-15
Substance
SODIUM FLUORIDE
Active strength
.9 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Wentworth Alcohol Free
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.9 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
562510Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5ed816ef-20bc-49ac-9202-8fac1edac579Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11527-735-16Wentworth Alcohol Free473 mL in 1 BOTTLE, PLASTICMOUTHWASH4731
11527-735-16Wentworth Alcohol Free1 in 1 CARTONMOUTHWASH11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11527-735-16ML - Milliliter11527-735f8576675-0ee4-4b75-9a42-5ac851c3ad1912021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11527-735WENTWORTH ALCOHOL FREE (SODIUM FLUORIDE) MOUTHWASH [SHEFFIELD PHARMACEUTICALS LLC]1Current NDC, Legacy NDC, 2 package rows20210427_5ed816ef-20bc-49ac-9202-8fac1edac579.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Wentworth Alcohol FreeSODIUM FLUORIDESheffield Pharmaceuticals LLC5ed816ef-20bc-49ac-9202-8fac1edac5792021-03-23Warnings, Adverse reactionsExact identifier
ndc (product): 11527-735

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562510sodium fluoride 0.2 % Oral RinsePSN5ed816ef-20bc-49ac-9202-8fac1edac5791
562510sodium fluoride 2 MG/ML MouthwashSCD5ed816ef-20bc-49ac-9202-8fac1edac5791
562510sodium fluoride 0.2 % MouthwashSY5ed816ef-20bc-49ac-9202-8fac1edac5791

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
11527-735-16115270735161 BOTTLE, PLASTIC in 1 CARTON (11527-735-16) / 473 mL in 1 BOTTLE, PLASTIC2021-04-150000-00-00NoNoCurrent