FDA.reportPublic FDA data

Vitamin A and D

Product NDC
69396-009
11-digit product format
693960009
Labeler code
69396
Product ID
69396-009_29b3cf7a-794a-6a29-e063-6294a90ac3d7
Type
HUMAN OTC DRUG
Nonproprietary name
Lanolin, Petrolatum
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Trifecta Pharmaceuticals USA LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-01-03
Substance
LANOLIN; PETROLATUM
Active strength
15.5; 53.4 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vitamin A and DLANOLIN, PETROLATUMTrifecta Pharmaceuticals USA LLC453dffec-de9d-0eac-e054-00144ff8d46c2024-12-20WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings For external use only When using this product avoid contact with eyes

Additional Listing Data#

Finished product
Yes
Brand name base
Vitamin A and D
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PETROLATUM15.5 g/100g
LANOLIN53.4 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4T6H12BN9U, 7EV65EAW6H
Rxcui664981

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69396-009-20Vitamin A and D15 g in 1 TUBEOINTMENT154
69396-009-20Vitamin A and D1 in 1 BOXOINTMENT14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-009VITAMIN A AND D (LANOLIN, PETROLATUM) OINTMENT [TRIFECTA PHARMACEUTICALS USA LLC]4Current NDC, Legacy NDC, 2 package rows20241222_453dffec-de9d-0eac-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
664981lanolin 15.5 % / petrolatum 53.4 % Topical OintmentPSN453dffec-de9d-0eac-e054-00144ff8d46c4
664981lanolin 0.155 MG/MG / petrolatum 0.534 MG/MG Topical OintmentSCD453dffec-de9d-0eac-e054-00144ff8d46c4
664981lanolin 15.5 % / petrolatum 53.4 % Topical OintmentSY453dffec-de9d-0eac-e054-00144ff8d46c4
664981lanolin 15.5 GM per 100 GM / petrolatum 53.4 GM per 100 GM Topical OintmentSY453dffec-de9d-0eac-e054-00144ff8d46c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69396-009-20693960009201 TUBE in 1 BOX (69396-009-20) / 15 g in 1 TUBE1 tube2017-01-030000-00-00NoNoCurrent