FDA.reportPublic FDA data

Grandma Els

Product NDC
68605-2007
11-digit product format
686052007
Labeler code
68605
Product ID
68605-2007_7a36640e-a45f-47af-9df8-1411df06ff97
Type
HUMAN OTC DRUG
Nonproprietary name
Diaper Rash Ointment
Dosage form
OINTMENT
Route
TOPICAL
Labeler
ABBE Laboratories, Inc.
Application
M347
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-02-01
Substance
LANOLIN; PETROLATUM
Active strength
.155; .7595 g/g; g/g
NDC exclude flag
No
Listing certified through
2027-12-31
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
Grandma ElsDIAPER RASH OINTMENTABBE Laboratories, Inc.b331c46d-855f-45f5-b3ee-3a611370face2026-01-10WarningsExact identifier

Warnings cross-check#

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

warnings

Warnings: For external use only

Additional Listing Data#

Finished product
Yes
Brand name base
Grandma Els
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PETROLATUM.155 g/g
LANOLIN.7595 g/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4T6H12BN9U, 7EV65EAW6H
Rxcui1649558

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68605-2007-3Grandma Els56.7 g in 1 TUBEOINTMENT56.77
68605-2007-4Grandma Els106.3 g in 1 JAROINTMENT106.37

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68605-2007GRANDMA ELS (DIAPER RASH OINTMENT) OINTMENT [ABBE LABORATORIES, INC.]6Current NDC, Legacy NDC, 2 package rows20241018_b331c46d-855f-45f5-b3ee-3a611370face.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649558lanolin 15.5 % / petrolatum 75.95 % Topical OintmentPSNb331c46d-855f-45f5-b3ee-3a611370face7
1649558lanolin 0.155 MG/MG / petrolatum 0.8 MG/MG Topical OintmentSCDb331c46d-855f-45f5-b3ee-3a611370face7
1649558lanolin 15.5 % / petrolatum 75.95 % Topical OintmentSYb331c46d-855f-45f5-b3ee-3a611370face7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68605-2007-36860520070356.7 g in 1 TUBE (68605-2007-3) 56.7 g2015-02-010000-00-00NoNoCurrent
68605-2007-468605200704106.3 g in 1 JAR (68605-2007-4) 106.3 g2015-02-010000-00-00NoNoCurrent