Zilactin-B

Product NDC
42829-550
11-digit product format
428290550
Labeler code
42829
Product ID
42829-550_42eec176-84ad-1e81-e063-6394a90afd01
Type
HUMAN OTC DRUG
Nonproprietary name
benzocaine
Dosage form
GEL
Route
TOPICAL
Labeler
ASCENT CONSUMER PRODUCTS, INC
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-11-06
Substance
BENZOCAINE
Active strength
.1 g/g
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Zilactin-B
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE.1 g/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU3RSY48JW5
Rxcui198488, 1542803

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42829-550-32Zilactin-B7 g in 1 TUBEGEL71
42829-550-32Zilactin-B1 in 1 CARTONGEL11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198488benzocaine 10 % Oral GelPSN42eeb3d4-bac6-4e29-e063-6294a90a644d1
1542803zilactin-B 10 % Oral GelPSN42eeb3d4-bac6-4e29-e063-6294a90a644d1
1542803benzocaine 0.1 MG/MG Oral Gel [Zilactin B]SBD42eeb3d4-bac6-4e29-e063-6294a90a644d1
198488benzocaine 0.1 MG/MG Oral GelSCD42eeb3d4-bac6-4e29-e063-6294a90a644d1
198488benzocaine 10 % Oral GelSY42eeb3d4-bac6-4e29-e063-6294a90a644d1
1542803Zilactin B 0.1 MG/MG Oral GelSY42eeb3d4-bac6-4e29-e063-6294a90a644d1
1542803Zilactin-B 10 % Mucosal GelSY42eeb3d4-bac6-4e29-e063-6294a90a644d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42829-550-32428290550321 TUBE in 1 CARTON (42829-550-32) / 7 g in 1 TUBE1 tube2025-11-06NoNoCurrent