FDA.reportPublic FDA data

Stomach Enzyme Formula

Product NDC
83027-0106
11-digit product format
830270106
Labeler code
83027
Product ID
83027-0106_70c1a075-b19d-4896-b019-754d83210cf2
Type
HUMAN OTC DRUG
Nonproprietary name
Betainum Muriaticum, Muriaticum Acidum, Natrum Phosphoricum, Pancreas Suis, Stomach (Suis) Symphytum Officinale, Pepsinum
Dosage form
SPRAY
Route
ORAL
Labeler
Nutritional Specialties, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2023-10-04
Substance
BETAINE HYDROCHLORIDE; COMFREY ROOT; HYDROCHLORIC ACID; PEPSIN; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SUS SCROFA PANCREAS; SUS SCROFA STOMACH
Active strength
6; 6; 6; 12; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Methylating Activity [MoA], Methylating Agent [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Stomach Enzyme Formula
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BETAINE HYDROCHLORIDE6 [hp_X]/mL
HYDROCHLORIC ACID6 [hp_X]/mL
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE6 [hp_X]/mL
SUS SCROFA PANCREAS12 [hp_X]/mL
SUS SCROFA STOMACH6 [hp_X]/mL
COMFREY ROOT6 [hp_X]/mL
PEPSIN6 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 7 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
JK8U8K4D6KInternal UNII lookup
QTT17582CBInternal UNII lookup
70WT22SF4BInternal UNII lookup
9Y3J3362RYInternal UNII lookup
T0920P9Z9AInternal UNII lookup
M9VVZ08EKQInternal UNII lookup
GID333S43JInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
992e6f61-abc9-4146-a9da-5ada4a627aa7Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83027-0106-1Stomach Enzyme Formula60 mL in 1 BOTTLE, SPRAYSPRAY601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83027-0106STOMACH ENZYME FORMULA (BETAINUM MURIATICUM, MURIATICUM ACIDUM, NATRUM PHOSPHORICUM, PANCREAS SUIS, STOMACH (SUIS) SYMPHYTUM OFFICINALE, PEPSINUM) SPRAY [NUTRITIONAL SPECIALTIES, INC.]1Current NDC, 1 package rows20231005_992e6f61-abc9-4146-a9da-5ada4a627aa7.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
Stomach Enzyme FormulaBETAINUM MURIATICUM, MURIATICUM ACIDUM, NATRUM PHOSPHORICUM, PANCREAS SUIS, STOMACH (SUIS) SYMPHYTUM OFFICINALE, PEPSINUMNutritional Specialties, Inc.992e6f61-abc9-4146-a9da-5ada4a627aa72023-10-04WarningsExact identifier
ndc (product): 83027-0106

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83027-0106-18302701060160 mL in 1 BOTTLE, SPRAY (83027-0106-1) 60 ml2023-10-04NoNoCurrent