Benzoin Tincture

Product NDC
82645-924
11-digit product format
826450924
Labeler code
82645
Product ID
82645-924_0d6cc91d-1d9b-25ae-e063-6394a90aa6a0
Type
HUMAN OTC DRUG
Nonproprietary name
Benzoin Resin
Dosage form
LIQUID
Route
TOPICAL
Labeler
Pharma Nobis, LLC
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2008-01-01
Substance
BENZOIN RESIN
Active strength
1000 mg/mL
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
Benzoin Tincture
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOIN RESIN1000 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
GK21SBA74RInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e42fccc2-1b4f-e7f3-e053-2a95a90aef39Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82645-924-92Benzoin Tincture59 mL in 1 BOTTLE, PLASTICLIQUID592

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82645-924BENZOIN TINCTURE (BENZOIN RESIN) LIQUID [PHARMA NOBIS, LLC]2Current NDC, Legacy NDC, 1 package rows20231227_e42fccc2-1b4f-e7f3-e053-2a95a90aef39.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 15 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Target Sensitive Whitening TPSODIUM FLUORIDETargetab9a129e-337b-31fe-e053-2995a90ac6912025-11-14WarningsExact identifier
application number: M022
Signature Care Sensitive Maximum StrengthPOTASSIUM NITRATE, SODIUM FLUORIDESafeway83225fe5-0490-eb4b-e053-2a91aa0a68792025-11-14WarningsExact identifier
application number: M022
Rite Aid Extra WhiteningFLUORIDERite Aidefe2c6c1-b8c6-4a52-b3c6-c9bfca4505702025-11-14WarningsExact identifier
application number: M022
Sound Body Sensitive Maximum StrengthPOTASSIUM NITRATE, SODIUM FLUORIDEBig Lots Stores, Inc.81a0a712-76e1-133f-e053-2a91aa0a001a2025-11-14WarningsExact identifier
application number: M022
Top Care Enamel GuardFLUORIDETOPCO Assoc. LLC8c5f7b56-6c53-47cf-b39a-cfa2e7fad40c2025-11-14WarningsExact identifier
application number: M022
Care One Maximum StrengthFLUORIDEAmerican Sales24715cc7-cf02-4ea0-a491-2a111ad3660e2025-11-14WarningsExact identifier
application number: M022
Kroger Enamel Protection Sensitive Gentle WhiteningPOTASSIUM NITRATE, SODIUM FLUORIDEKroger Company82b9a954-2a53-ac56-e053-2991aa0abd0e2025-11-13WarningsExact identifier
application number: M022
Sensitive Extra WhiteningSODIUM FLUORIDEPublix Super Market16eddce3-03e4-4c0e-e063-6294a90ae94d2025-11-13WarningsExact identifier
application number: M022
Pronamel Repair WhiteningPRONAMEL REPAIR WHITENINGPublix Super Market Inc16ee2625-3641-205d-e063-6394a90a742f2025-11-13WarningsExact identifier
application number: M022
Rite Aid Maximum StrengthBENZOCAINERite Aid340ccdab-0a02-454c-8d44-ced5667276ab2025-11-13WarningsExact identifier
application number: M022
3x Medicated Mouth Sore GelBENZOCAINECVSa7572c4f-089b-0e80-e053-2a95a90a0ddf2025-11-13WarningsExact identifier
application number: M022
3x Medicated Mouth Sore GelBENZOCAINEWalgreensad509f2a-05de-6c77-e053-2995a90ae5262025-11-13WarningsExact identifier
application number: M022
TopCare Oral Pain Relief Maximum StrengthBENZOCAINETopco Associates LLC835fb6ac-dbb7-5566-e053-2991aa0af5e22025-11-13WarningsExact identifier
application number: M022
4x Medicated Toothache and Gum GelBENZOCAINEWalgreensa71c47de-d35d-49da-e053-2995a90a823c2025-11-13WarningsExact identifier
application number: M022
4X Medicated Toothache and Gum GelBENZOCAINEWalmarta471a858-edbf-c31e-e053-2995a90a71562025-11-13WarningsExact identifier
application number: M022
4X Medicated Severe Toothache and Gum CreamBENZOCAINERite Aid996fdbeb-1fe3-77b6-e053-2995a90a25c72025-11-13WarningsExact identifier
application number: M022
Topco 4x Medicated Toothache and Gum GelBENZOCAINETopCareb463ea94-08a9-ca5d-e053-2a95a90a224b2025-11-13WarningsExact identifier
application number: M022
4X Medicated Severe Toothache and Gum GelBENZOCAINERite Aid99703bf4-f169-5e05-e053-2995a90afab42025-11-13WarningsExact identifier
application number: M022
3X Medicated Mouth Sore GelBENZOCAINERite Aid997064c9-24bb-7fb1-e053-2995a90ace7c2025-11-13WarningsExact identifier
application number: M022
Quality Choice Natural WhiteFLUORIDECHAIN DRUG MARKETING ASSOCIATION INC8d187823-7e56-441b-8bca-8f03e7bb07c72025-11-12WarningsExact identifier
application number: M022

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82645-924-928264509249259 mL in 1 BOTTLE, PLASTIC (82645-924-92) 59 ml2017-12-120000-00-00NoNoCurrent