PEDOXAN Extract

Product NDC
73442-0014
11-digit product format
734420014
Labeler code
73442
Product ID
73442-0014_af69d604-180d-702f-e053-2a95a90a2ae4
Type
HUMAN OTC DRUG
Nonproprietary name
citrus unshiu peel, saposhnikovia root, acetaminophen, dextromethorphan hydrobromide
Dosage form
GRANULE
Route
ORAL
Labeler
I World Pharmaceutical Co., Ltd.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2020-09-16
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; SAPOSHNIKOVIA DIVARICATA ROOT; TANGERINE
Active strength
.06; .00425; 1; 1 g/3g; g/3g; g/3g; g/3g
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Fruit Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN.06 g/3g
DEXTROMETHORPHAN HYDROBROMIDE.00425 g/3g
SAPOSHNIKOVIA DIVARICATA ROOT1 g/3g
TANGERINE1 g/3g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, 9D2RTI9KYH, 8H84LFK2QD, KH3E3096OO

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73442-0014-1PEDOXAN Extract3 g in 1 POUCHGRANULE31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73442-0014PEDOXAN EXTRACT (CITRUS UNSHIU PEEL, SAPOSHNIKOVIA ROOT, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE) GRANULE [I WORLD PHARMACEUTICAL CO., LTD.]1Current NDC, Legacy NDC, 1 package rows20200916_af69d604-180c-702f-e053-2a95a90a2ae4.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
73442-0014-1734420014013 g in 1 POUCH (73442-0014-1) 3 g2020-09-160000-00-00NoNoCurrent