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
TANGERINE.06 g/3g
ACETAMINOPHEN.00425 g/3g
SAPOSHNIKOVIA DIVARICATA ROOT1 g/3g
DEXTROMETHORPHAN HYDROBROMIDE1 g/3g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
KH3E3096OOInternal UNII lookup
362O9ITL9DInternal UNII lookup
8H84LFK2QDInternal UNII lookup
9D2RTI9KYHInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
af69d604-180c-702f-e053-2a95a90a2ae4Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PEDOXAN ExtractCITRUS UNSHIU PEEL, SAPOSHNIKOVIA ROOT, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEI World Pharmaceutical Co., Ltd.af69d604-180c-702f-e053-2a95a90a2ae42020-09-16WarningsExact identifier
ndc (product): 73442-0014

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