NIVAGEN ZINC OXIDE

Product NDC
75834-170
11-digit product format
758340170
Labeler code
75834
Product ID
75834-170_9b087880-cd9b-4a0e-be76-dcb0ad2fd11f
Type
HUMAN OTC DRUG
Nonproprietary name
zinc oxide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Nivagen Pharmaceuticals, Inc.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-05-10
Substance
ZINC OXIDE
Active strength
200 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
NIVAGEN ZINC OXIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE200 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSOI2LOH54Z
Rxcui198911

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75834-170-01NIVAGEN ZINC OXIDE28.4 g in 1 TUBEOINTMENT28.46
75834-170-02NIVAGEN ZINC OXIDE56.7 g in 1 TUBEOINTMENT56.76
75834-170-15NIVAGEN ZINC OXIDE425 g in 1 JAROINTMENT4256

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75834-170-01GM - Gram75834-17023ca029a-7091-40a4-a489-8313dd3bb72412018-09-05
75834-170-02GM - Gram75834-170f8f42b83-1876-4fba-8afb-3e5afc59604112018-09-05
75834-170-15GM - Gram75834-170f19b2880-a7bd-4f80-8848-45964e81175512018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75834-170NIVAGEN ZINC OXIDE (ZINC OXIDE) OINTMENT [NIVAGEN PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 3 package rows20250212_7b42655b-2163-4637-9f5d-1d2efa1bdf1d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198911zinc oxide 20 % Topical OintmentPSN7b42655b-2163-4637-9f5d-1d2efa1bdf1d6
198911zinc oxide 0.2 MG/MG Topical OintmentSCD7b42655b-2163-4637-9f5d-1d2efa1bdf1d6
198911zinc oxide 20 % Topical OintmentSY7b42655b-2163-4637-9f5d-1d2efa1bdf1d6
198911zinc oxide 200 MG per GM Topical OintmentSY7b42655b-2163-4637-9f5d-1d2efa1bdf1d6
198911ZNO 0.2 MG/MG Topical OintmentSY7b42655b-2163-4637-9f5d-1d2efa1bdf1d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75834-170-017583401700128.4 g in 1 TUBE (75834-170-01) 28.4 g2018-05-100000-00-00NoNoCurrent
75834-170-027583401700256.7 g in 1 TUBE (75834-170-02) 56.7 g2018-05-100000-00-00NoNoCurrent
75834-170-1575834017015425 g in 1 JAR (75834-170-15) 425 g2018-05-100000-00-00NoNoCurrent