FDA.reportPublic FDA data

Asteroid

Product NDC
84107-552
11-digit product format
841070552
Labeler code
84107
Product ID
84107-552_189c8229-fb43-4cd9-a389-b147637f809e
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol, Petrolatum, Zinc Oxide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
HEALTHTEX LIMITED
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-07-22
Substance
MENTHOL; PETROLATUM; ZINC OXIDE
Active strength
.098; 22.302; 1.4 g/28g; g/28g; g/28g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL.098 g/28g
PETROLATUM22.302 g/28g
ZINC OXIDE1.4 g/28g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL7T10EIP3A, 4T6H12BN9U, SOI2LOH54Z
Rxcui2720028

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84107-552-02Asteroid1 in 1 CARTONOINTMENT12
84107-552-02Asteroid28 g in 1 TUBEOINTMENT282

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2720028menthol 0.35 % / petrolatum 79.65 % / zinc oxide 5 % Rectal OintmentPSN29d1e46d-0189-4f9e-9963-8a9de2757f282
2720028menthol 0.0035 MG/MG / petrolatum 0.797 MG/MG / zinc oxide 0.05 MG/MG Rectal OintmentSCD29d1e46d-0189-4f9e-9963-8a9de2757f282
2720028menthol 0.0035 MG/MG / petrolatum 0.797 MG/MG / ZNO 0.05 MG/MG Rectal OintmentSY29d1e46d-0189-4f9e-9963-8a9de2757f282
2720028menthol 0.35 % / petrolatum 79.65 % / zinc oxide 5 % Rectal OintmentSY29d1e46d-0189-4f9e-9963-8a9de2757f282

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84107-552-02841070552021 TUBE in 1 CARTON (84107-552-02) / 28 g in 1 TUBE1 tube2025-07-22NoNoCurrent