Teeth-Gums

Product NDC
55714-2528
Requested package NDC
55714-2528-1
11-digit product format
557142528
Labeler code
55714
Product ID
55714-2528_2dd1c2a8-6aa6-e2c6-e063-6394a90a2872
Type
HUMAN OTC DRUG
Nonproprietary name
Chamomilla, Echinacea, Aconitum napellus, Arnica montana, Arsenicum album, Baptisia tinctoria, Belladonna, Bryonia, Calendula officinalis, Chamomilla, Chelidonium majus, Crotalus horridus, Gelsemium sempervirens, Hepar sulphuris calcareum, Kreosotum, Mercurius vivus, Myrrha, Nux vomica, Phosphorus, Phytolacca decandra, Plantago major, Rhus toxicodendron, Silicea, Staphysagria
Dosage form
LIQUID
Route
ORAL
Labeler
Newton Laboratories, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-01-01
Substance
ACONITUM NAPELLUS; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; CHELIDONIUM MAJUS; CROTALUS HORRIDUS HORRIDUS VENOM; DELPHINIUM STAPHISAGRIA SEED; ECHINACEA, UNSPECIFIED; GELSEMIUM SEMPERVIRENS ROOT; MATRICARIA CHAMOMILLA; MERCURY; MYRRH; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PLANTAGO MAJOR; SILICON DIOXIDE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; WOOD CREOSOTE
Active strength
15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 6; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [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; [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], 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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55714-252855714-2528-1UExcluded because listing certification expiredexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55714-252855714-2528-1UExcluded because listing certification expiredexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55714-252855714-2528-1UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

Additional Listing Data#

Finished product
Yes
Brand name base
Teeth-Gums
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DELPHINIUM STAPHISAGRIA SEED15 [hp_X]/mL
ECHINACEA, UNSPECIFIED15 [hp_X]/mL
ARSENIC TRIOXIDE15 [hp_X]/mL
BAPTISIA TINCTORIA ROOT15 [hp_X]/mL
ATROPA BELLADONNA15 [hp_X]/mL
BRYONIA ALBA ROOT15 [hp_X]/mL
CALENDULA OFFICINALIS FLOWERING TOP15 [hp_X]/mL
MATRICARIA CHAMOMILLA15 [hp_X]/mL
CHELIDONIUM MAJUS15 [hp_X]/mL
CROTALUS HORRIDUS HORRIDUS VENOM15 [hp_X]/mL
ACONITUM NAPELLUS15 [hp_X]/mL
CALCIUM SULFIDE6 [hp_X]/mL
WOOD CREOSOTE15 [hp_X]/mL
MERCURY15 [hp_X]/mL
MYRRH15 [hp_X]/mL
STRYCHNOS NUX-VOMICA SEED15 [hp_X]/mL
PHOSPHORUS15 [hp_X]/mL
PHYTOLACCA AMERICANA ROOT15 [hp_X]/mL
PLANTAGO MAJOR15 [hp_X]/mL
TOXICODENDRON PUBESCENS LEAF15 [hp_X]/mL
SILICON DIOXIDE15 [hp_X]/mL
ARNICA MONTANA15 [hp_X]/mL
GELSEMIUM SEMPERVIRENS ROOT15 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 2 · 23 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
00543AP1JVInternal UNII lookup
4N9P6CC1DXInternal UNII lookup
S7V92P67HOInternal UNII lookup
5EF0HWI5WUInternal UNII lookup
WQZ3G9PF0HInternal UNII lookup
T7J046YI2BInternal UNII lookup
18E7415PXQInternal UNII lookup
G0R4UBI2ZZInternal UNII lookup
7E889U5RNNInternal UNII lookup
YHA2XLJ956Internal UNII lookup
U0NQ8555JDInternal UNII lookup
1MBW07J51QInternal UNII lookup
3JYG22FD73Internal UNII lookup
FXS1BY2PGLInternal UNII lookup
JC71GJ1F3LInternal UNII lookup
269XH13919Internal UNII lookup
27YLU75U4WInternal UNII lookup
11E6VI8VEGInternal UNII lookup
W2469WNO6UInternal UNII lookup
6IO182RP7AInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9d27b1e4-a966-5495-e053-2a95a90a965bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2528-1Teeth-Gums30 mL in 1 BOTTLE, GLASSLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2528TEETH-GUMS (CHAMOMILLA, ECHINACEA, ACONITUM NAPELLUS, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BELLADONNA, BRYONIA, CALENDULA OFFICINALIS, CHAMOMILLA, CHELIDONIUM MAJUS, CROTALUS HORRIDUS, GELSEMIUM SEMPERVIRENS, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, MERCURIUS VIVUS, MYRRHA, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PLANTAGO MAJOR, RHUS TOXICODENDRON, SILICEA, STAPHYSAGRIA) LIQUID [NEWTON LABORATORIES, INC.]2Current NDC, Legacy NDC, 1 package rows20250212_9d27b1e4-a966-5495-e053-2a95a90a965b.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
Teeth-GumsCHAMOMILLA, ECHINACEA, ACONITUM NAPELLUS, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BELLADONNA, BRYONIA, CALENDULA OFFICINALIS, CHAMOMILLA, CHELIDONIUM MAJUS, CROTALUS HORRIDUS, GELSEMIUM SEMPERVIRENS, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, MERCURIUS VIVUS, MYRRHA, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PLANTAGO MAJOR, RHUS TOXICODENDRON, SILICEA, STAPHYSAGRIANewton Laboratories, Inc.9d27b1e4-a966-5495-e053-2a95a90a965b2025-02-10WarningsExact identifier
ndc (package): 55714-2528-1
ndc (product): 55714-2528
ndc11 (package): 55714252801

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55714-2528-15571425280130 mL in 1 BOTTLE, GLASS (55714-2528-1) 30 ml2019-01-010000-00-00NoNoCurrent