Heartburn

Product NDC
51393-5005
11-digit product format
513935005
Labeler code
51393
Product ID
51393-5005_511cbb23-be77-5139-e063-6394a90a8cd0
Type
HUMAN OTC DRUG
Nonproprietary name
Garlic, Berberis Vulgaris Root, Calendula Officinalis Flowering Top, Iris Versicolor Root, Ginger, and Valerian
Dosage form
SOLUTION/ DROPS
Route
SUBLINGUAL
Labeler
Forces of Nature
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2020-10-01
Substance
BERBERIS VULGARIS ROOT; CALENDULA OFFICINALIS FLOWERING TOP; GARLIC; GINGER; IRIS VERSICOLOR ROOT; VALERIAN
Active strength
6; 6; 89; 89; 12; 12 [hp_X]/100mL; [hp_X]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL
Pharmacologic classes
Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Heartburn
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GARLIC89 [hp_C]/100mL
BERBERIS VULGARIS ROOT6 [hp_X]/100mL
CALENDULA OFFICINALIS FLOWERING TOP6 [hp_X]/100mL
IRIS VERSICOLOR ROOT12 [hp_C]/100mL
GINGER89 [hp_C]/100mL
VALERIAN12 [hp_C]/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V1V998DC17Internal UNII lookup
ITJ40JX79UInternal UNII lookup
18E7415PXQInternal UNII lookup
X43D4L3DQCInternal UNII lookup
C5529G5JPQInternal UNII lookup
JWF5YAW3QWInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
35e12e83-5808-4f78-bcd5-33217a0d291bAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51393-5005-12026-01-29C16284748780-149896155-ade9-586f-e063-e6dba90add90Heartburn
51393-5005-32026-01-29C16284748780-149896155-ade9-586f-e063-e6dba90add90Heartburn

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51393-5005-1Heartburn10 mL in 1 BOTTLE, DISPENSINGSOLUTION/ DROPS104
51393-5005-1Heartburn1 in 1 CARTONSOLUTION/ DROPS14
51393-5005-3Heartburn1 in 1 CARTONSOLUTION/ DROPS14
51393-5005-3Heartburn30 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51393-5005HEARTBURN (GARLIC, BERBERIS VULGARIS ROOT, CALENDULA OFFICINALIS FLOWERING TOP, IRIS VERSICOLOR ROOT, GINGER, AND VALERIAN) SOLUTION/ DROPS [FORCES OF NATURE]2Current NDC, Legacy NDC, 4 package rows20210710_35e12e83-5808-4f78-bcd5-33217a0d291b.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
HeartburnGARLIC, BERBERIS VULGARIS ROOT, CALENDULA OFFICINALIS FLOWERING TOP, IRIS VERSICOLOR ROOT, GINGER, AND VALERIANForces of Nature35e12e83-5808-4f78-bcd5-33217a0d291b2026-05-05WarningsExact identifier
ndc (product): 51393-5005

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51393-5005-1513935005011 BOTTLE, DISPENSING in 1 CARTON (51393-5005-1) / 10 mL in 1 BOTTLE, DISPENSING2020-10-010000-00-00NoNoCurrent
51393-5005-3513935005031 BOTTLE, DROPPER in 1 CARTON (51393-5005-3) / 30 mL in 1 BOTTLE, DROPPER2021-08-010000-00-00NoNoCurrent