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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiITJ40JX79U, 18E7415PXQ, V1V998DC17, C5529G5JPQ, X43D4L3DQC, JWF5YAW3QW

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

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