D-119

Product NDC
58264-0125
11-digit product format
582640125
Labeler code
58264
Product ID
58264-0125_2b9edb0e-49a1-f422-e063-6294a90ae8fa
Type
HUMAN OTC DRUG
Nonproprietary name
Plantago major, Delphinium staphisagria seed, Matricaria chamomilla, Sepia officinalis juice, Arnica montana, Hypericum perforatum, Strychnos nux-vomica seed, Spigelia anthelmia, Iron, Barium carbonate, Veratrum album root, Calcium fluoride, Antipyrine, and Bismuth subnitrate
Dosage form
SOLUTION
Route
SUBLINGUAL
Labeler
DNA Labs, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1990-01-01
Substance
ANTIPYRINE; ARNICA MONTANA; BARIUM CARBONATE; BISMUTH SUBNITRATE; CALCIUM FLUORIDE; DELPHINIUM STAPHISAGRIA SEED; HYPERICUM PERFORATUM; IRON; MATRICARIA CHAMOMILLA; PLANTAGO MAJOR; SEPIA OFFICINALIS JUICE; SPIGELIA ANTHELMIA; STRYCHNOS NUX-VOMICA SEED; VERATRUM ALBUM ROOT
Active strength
12; 6; 8; 8; 8; 12; 6; 8; 30; 6; 6; 6; 4; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Allergens [CS], Bismuth [CS], Bismuth [EPC], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
D-119
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ANTIPYRINE12 [hp_X]/mL
ARNICA MONTANA6 [hp_X]/mL
BARIUM CARBONATE8 [hp_X]/mL
BISMUTH SUBNITRATE8 [hp_X]/mL
CALCIUM FLUORIDE8 [hp_X]/mL
DELPHINIUM STAPHISAGRIA SEED12 [hp_X]/mL
HYPERICUM PERFORATUM6 [hp_X]/mL
IRON8 [hp_X]/mL
MATRICARIA CHAMOMILLA30 [hp_X]/mL
PLANTAGO MAJOR6 [hp_X]/mL
SEPIA OFFICINALIS JUICE6 [hp_X]/mL
SPIGELIA ANTHELMIA6 [hp_X]/mL
STRYCHNOS NUX-VOMICA SEED4 [hp_X]/mL
VERATRUM ALBUM ROOT6 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiT3CHA1B51H, O80TY208ZW, 6P669D8HQ8, H19J064BA5, O3B55K4YKI, 00543AP1JV, XK4IUX8MNB, E1UOL152H7, G0R4UBI2ZZ, W2469WNO6U, QDL83WN8C2, WYT05213GE, 269XH13919, QNS6W5US1Z

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313
910c1bd7-67d1-44c7-ad4f-9445f827edccProduct name120230808

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58264-0125-12022-06-06C16284748780-19d75b9d0-ba40-f424-e053-dadaa90a57ceD-119
58264-0125-12020-01-31C16284748780-19d75b9d0-ba40-f424-e053-dadaa90a57ceD-119

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58264-0125-1D-11929.57 mL in 1 BOTTLE, GLASSSOLUTION29.573

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58264-0125D-119 (PLANTAGO MAJOR, DELPHINIUM STAPHISAGRIA SEED, MATRICARIA CHAMOMILLA, SEPIA OFFICINALIS JUICE, ARNICA MONTANA, HYPERICUM PERFORATUM, STRYCHNOS NUX-VOMICA SEED, SPIGELIA ANTHELMIA, IRON, BARIUM CARBONATE, VERATRUM ALBUM ROOT, CALCIUM FLUORIDE, ANTIPYRINE, AND BISMUTH SUBNITRATE) SOLUTION [DNA LABS, INC.]3Current NDC, Legacy NDC, 1 package rows20250115_c9463aa1-ac37-42f9-bc2b-785e3d2befad.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58264-0125-15826401250129.57 mL in 1 BOTTLE, GLASS (58264-0125-1) 29.57 ml1990-01-010000-00-00NoNoCurrent