SOUTH MOON Toothache

Product NDC
84983-005
11-digit product format
849830005
Labeler code
84983
Product ID
84983-005_449ef9f9-2616-7e8d-e063-6294a90a8a7b
Type
HUMAN OTC DRUG
Nonproprietary name
GLYCERIN
Dosage form
LIQUID
Route
TOPICAL
Labeler
Shantou South Moon Biotechnology Co., Ltd.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-04-14
Substance
MENTHA X PIPERITA WHOLE
Active strength
.06 mg/20mg
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SOUTH MOON Toothache
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHA X PIPERITA WHOLE.06 mg/20mg

Harmonized Identifiers#

Field, Values table
FieldValues
Unii79M2M2UDA9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84983-005-01SOUTH MOON Toothache20 mg in 1 BOXLIQUID202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84983-005SOUTH MOON TOOTHACHE (GLYCERIN) LIQUID [SHANTOU SOUTH MOON BIOTECHNOLOGY CO., LTD.]1Current NDC, 1 package rows20250417_32b8bbfd-097a-dae4-e063-6294a90ac0d6.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84983-005-018498300050120 mg in 1 BOX (84983-005-01) 20 mg2025-04-14NoNoCurrent