Teething-Colic

Product NDC
55714-1530
11-digit product format
557141530
Labeler code
55714
Product ID
55714-1530_42f36188-97a7-5c4b-e063-6394a90ae52d
Type
HUMAN OTC DRUG
Nonproprietary name
Chamomilla, Valeriana officinalis, Aconitum napellus, Apis mellifica, Baptisia tinctoria, Belladonna, Borax, Bryonia, Calcarea carbonica, Calcarea phosphorica, Chamomilla, Chelidonium majus, Coffea cruda, Collinsonia canadensis, Colocynthis, Kreosotum, Magnesia phosphorica, Nux vomica, Podophyllum peltatum, Rheum, Scutellaria lateriflora, Silicea, Terebinthina, Zingiber officinale
Dosage form
LIQUID
Route
ORAL
Labeler
Newton Laboratories, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-01-01
Substance
ACONITUM NAPELLUS; APIS MELLIFERA; ARABICA COFFEE BEAN; ATROPA BELLADONNA; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CITRULLUS COLOCYNTHIS FRUIT PULP; COLLINSONIA CANADENSIS ROOT; GINGER; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MATRICARIA CHAMOMILLA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PODOPHYLLUM; RHEUM OFFICINALE ROOT; SCUTELLARIA LATERIFLORA WHOLE; SILICON DIOXIDE; SODIUM BORATE; STRYCHNOS NUX-VOMICA SEED; TRIBASIC CALCIUM PHOSPHATE; TURPENTINE OIL; VALERIAN; WOOD CREOSOTE
Active strength
15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 6; 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], Allergens [CS], Allergens [CS], Allergens [CS], Bee Venoms [CS], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], 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], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Seed Storage Proteins [CS], Standardized Insect Venom Allergenic Extract [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55714-1530-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55714-1530-10efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Teething-Colic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VALERIAN6 [hp_X]/mL
COLLINSONIA CANADENSIS ROOT15 [hp_X]/mL
APIS MELLIFERA15 [hp_X]/mL
BAPTISIA TINCTORIA ROOT15 [hp_X]/mL
ATROPA BELLADONNA15 [hp_X]/mL
SODIUM BORATE15 [hp_X]/mL
BRYONIA ALBA ROOT15 [hp_X]/mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE15 [hp_X]/mL
TRIBASIC CALCIUM PHOSPHATE15 [hp_X]/mL
MATRICARIA CHAMOMILLA15 [hp_X]/mL
CHELIDONIUM MAJUS15 [hp_X]/mL
ARABICA COFFEE BEAN15 [hp_X]/mL
WOOD CREOSOTE15 [hp_X]/mL
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE15 [hp_X]/mL
STRYCHNOS NUX-VOMICA SEED15 [hp_X]/mL
PODOPHYLLUM15 [hp_X]/mL
RHEUM OFFICINALE ROOT15 [hp_X]/mL
SCUTELLARIA LATERIFLORA WHOLE15 [hp_X]/mL
SILICON DIOXIDE15 [hp_X]/mL
TURPENTINE OIL15 [hp_X]/mL
GINGER15 [hp_X]/mL
CITRULLUS COLOCYNTHIS FRUIT PULP15 [hp_X]/mL
ACONITUM NAPELLUS15 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 2 · 23 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
JWF5YAW3QWInternal UNII lookup
O2630F3XDRInternal UNII lookup
7S82P3R43ZInternal UNII lookup
5EF0HWI5WUInternal UNII lookup
WQZ3G9PF0HInternal UNII lookup
91MBZ8H3QOInternal UNII lookup
T7J046YI2BInternal UNII lookup
2E32821G6IInternal UNII lookup
91D9GV0Z28Internal UNII lookup
G0R4UBI2ZZInternal UNII lookup
7E889U5RNNInternal UNII lookup
3SW678MX72Internal UNII lookup
3JYG22FD73Internal UNII lookup
HF539G9L3QInternal UNII lookup
269XH13919Internal UNII lookup
2S713A4VP3Internal UNII lookup
A47JP5ZG9MInternal UNII lookup
7BP4DH5PDCInternal UNII lookup
ETJ7Z6XBU4Internal UNII lookup
C5H0QJ6V7FInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9db30229-3031-ff10-e053-2995a90aff75Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-1530-1Teething-Colic30 mL in 1 BOTTLE, GLASSLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-1530TEETHING-COLIC (CHAMOMILLA, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, APIS MELLIFICA, BAPTISIA TINCTORIA, BELLADONNA, BORAX, BRYONIA, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CHAMOMILLA, CHELIDONIUM MAJUS, COFFEA CRUDA, COLLINSONIA CANADENSIS, COLOCYNTHIS, KREOSOTUM, MAGNESIA PHOSPHORICA, NUX VOMICA, PODOPHYLLUM PELTATUM, RHEUM, SCUTELLARIA LATERIFLORA, SILICEA, TEREBINTHINA, ZINGIBER OFFICINALE) LIQUID [NEWTON LABORATORIES, INC.]2Current NDC, Legacy NDC, 1 package rows20250129_9db30229-3031-ff10-e053-2995a90aff75.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
Teething-ColicCHAMOMILLA, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, APIS MELLIFICA, BAPTISIA TINCTORIA, BELLADONNA, BORAX, BRYONIA, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CHAMOMILLA, CHELIDONIUM MAJUS, COFFEA CRUDA, COLLINSONIA CANADENSIS, COLOCYNTHIS, KREOSOTUM, MAGNESIA PHOSPHORICA, NUX VOMICA, PODOPHYLLUM PELTATUM, RHEUM, SCUTELLARIA LATERIFLORA, SILICEA, TEREBINTHINA, ZINGIBER OFFICINALENewton Laboratories, Inc.9db30229-3031-ff10-e053-2995a90aff752025-11-06WarningsExact identifier
ndc (product): 55714-1530

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55714-1530-15571415300130 mL in 1 BOTTLE, GLASS (55714-1530-1) 30 ml2019-01-010000-00-00NoNoCurrent