ANTI-H.PYLORI FORMULA

Product NDC
85631-016
11-digit product format
856310016
Labeler code
85631
Product ID
85631-016_468a15c7-c6f9-ed82-e063-6294a90a5520
Type
HUMAN OTC DRUG
Nonproprietary name
REISHI YEAST FU LING OPHIOPOGON JAPONICUS WHOLE
Dosage form
CAPSULE
Route
ORAL
Labeler
Bispit Canada Ltd.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2025-12-22
Substance
FU LING; OPHIOPOGON JAPONICUS WHOLE; REISHI; YEAST
Active strength
3; 3.5; 50; 6 g/100g; g/100g; g/100g; g/100g
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ANTI-H.PYLORI FORMULA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FU LING3 g/100g
OPHIOPOGON JAPONICUS WHOLE3.5 g/100g
REISHI50 g/100g
YEAST6 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiXH37TWY5O4, 2983RA66TS, TKD8LH0X2Z, 3NY3SM6B8U

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85631-016-01ANTI-H.PYLORI FORMULA0.8 g in 1 CAPSULECAPSULE0.81
85631-016-01ANTI-H.PYLORI FORMULA90 in 1 BOTTLECAPSULE901

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85631-016-018563100160190 CAPSULE in 1 BOTTLE (85631-016-01) / .8 g in 1 CAPSULE90 capsule2025-12-22NoNoHistorical