Precaine B

Product NDC
10866-0087
11-digit product format
108660087
Labeler code
10866
Product ID
10866-0087_f03928f8-ca55-60c2-e053-2995a90a6150
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzocaine Topical Anesthetic
Dosage form
GEL
Route
DENTAL
Labeler
Pascal Company, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2009-04-27
Marketing end
0000-00-00
Substance
BENZOCAINE
Active strength
221 mg/g
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10866-0087-12024-01-30C16284748780-1d6a99b39-3849-a426-e053-dadaa90af4c2Precaine B
10866-0087-12022-12-19C16284748780-1d6a99b39-3849-a426-e053-dadaa90af4c2Precaine B
10866-0087-12022-01-28C16284748780-1d6a99b39-3849-a426-e053-dadaa90af4c2Precaine B

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10866-0087-1Precaine B30 g in 1 JARGEL303

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZOCAINEACTIVE INGREDIENTU3RSY48JW5PRECAINE B (BENZOCAINE TOPICAL ANESTHETIC) GEL [PASCAL COMPANY, INC.]1
BENZOCAINEACTIVE MOIETYU3RSY48JW5PRECAINE B (BENZOCAINE TOPICAL ANESTHETIC) GEL [PASCAL COMPANY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10866-0087PRECAINE B (BENZOCAINE TOPICAL ANESTHETIC) GEL [PASCAL COMPANY, INC.]3Legacy NDC, 1 package rows20221221_1a4c0efc-bcfd-671f-e054-00144ff88e88.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10866-0087-11086600870130 g in 1 JAR (10866-0087-1) 30 g2009-04-270000-00-00NoNoCurrent