FDA.reportPublic FDA data

Teething - Colic

Manufacturer
Newton Laboratories, Inc.
Effective date
2011-03-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:04:55

Label at a glance#

ProductTeething - Colic
Active ingredientAconitum Napellus, Apis Mellifera, Baptisia Tinctoria, Atropa Belladonna, Sodium Borate, Bryonia Alba Root, Oyster Shell Calcium Carbonate, Crude, Tribasic Calcium Phosphate, Matricaria Recutita, Chelidonium Majus, Arabica Coffee Bean, Collinsonia Canadensis Root, Citrullus Colocynthis Fruit Pulp, Wood Creosote, Magnesium Phosphate, Dibasic Trihydrate, Strychnos Nux-vomica Seed, Podophyllum, Rheum Officinale Root, Scutellaria Lateriflora, Silicon Dioxide, Turpentine Oil, Ginger, Valerian
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Teething - Colic   Formulated for associated symptoms such as inconsolable crying, painful and swollen gums, sleeplessness and digestive discomfort.

DOSAGE & ADMINISTRATION SECTION

Directions: ORAL USE ONLY - SHAKE WELL.   Children, ages 0 to 11, give 3 drops orally (ages 12 and up, give 6 drops) as needed or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Aconitum nap. 10x, Apis mel. 10x, Baptisia 10x, Belladonna 10x, Borax 10x, Bryonia 10x, Calc. carb.10x, Calc. phos. 10x, Chamomilla 10x, Chelidonium majus 10x, Coffea cruda 10x, Collinsonia 10x, Colocynthis 10x, Kreosotum 10x, Mag.phos. 10x, Nux vom. 10x, Podoph. pelt. 10x, Rheum 10x, Scutellaria lateriflora 10x, Silicea 10x, Terebinthina 10x, Zingiber 10x, Chamomilla 3x, Valeriana 3x.

OTC - PURPOSE SECTION

Formulated for associated symptoms such as inconsolable crying, painful and swollen gums, sleeplessness and digestive discomfort.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%.  

QUESTIONS SECTION

OTC - QUESTIONS SECTION

www.newtonlabs.net  Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions?  1.800.448.7256

WARNINGS SECTION

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.  

OTC - PREGNANCY OR BREAST FEEDING SECTION

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package label
package label

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55714-1509-02020-01-31C16284748780-19d75b9d0-9730-f424-e053-dadaa90a57ceTeething - Colic
55714-1509-12020-01-31C16284748780-19d75b9d0-9730-f424-e053-dadaa90a57ceTeething - Colic
55714-1509-22020-01-31C16284748780-19d75b9d0-9730-f424-e053-dadaa90a57ceTeething - Colic

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-1509-0Teething - Colic.5 mL in 1 BOTTLE, GLASSLIQUID.51
55714-1509-1Teething - Colic29.57 mL in 1 BOTTLE, GLASSLIQUID29.571
55714-1509-2Teething - Colic59.14 mL in 1 BOTTLE, GLASSLIQUID59.141

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-1509TEETHING - COLIC (ACONITUM NAP., APIS MEL., BAPTISIA, BELLADONNA, BORAX, BRYONIA, CALC. CARB., CALC. PHOS., CHAMOMILLA, CHELIDONIUM MAJUS, COFFEA CRUDA, COLLINSONIA, COLOCYNTHIS, KREOSOTUM, MAG.PHOS., NUX VOM., PODOPH. PELT., RHEUM, SCUTELLARIALATERIFLORA, SILICEA, TEREBINTHINA, ZINGIBER, VALERIANA) LIQUID [NEWTON LABORATORIES, INC.]1Legacy NDC, 3 package rows20130827_5484d315-d121-77ff-0445-16cbad3f078e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Aconitum NapellusACTIVE INGREDIENTU0NQ8555JD1
Apis MelliferaACTIVE INGREDIENT7S82P3R43Z1
Arabica Coffee BeanACTIVE INGREDIENT3SW678MX721
Atropa BelladonnaACTIVE INGREDIENTWQZ3G9PF0H1
Baptisia TinctoriaACTIVE INGREDIENT5K1UO2888Y1
Bryonia Alba RootACTIVE INGREDIENTT7J046YI2B1
Chelidonium MajusACTIVE INGREDIENT7E889U5RNN1
Citrullus Colocynthis Fruit PulpACTIVE INGREDIENT23H32AOH171
Collinsonia Canadensis RootACTIVE INGREDIENTO2630F3XDR1
GingerACTIVE INGREDIENTC5529G5JPQ1
Magnesium Phosphate, Dibasic TrihydrateACTIVE INGREDIENTHF539G9L3Q1
Matricaria RecutitaACTIVE INGREDIENTG0R4UBI2ZZ1
Oyster Shell Calcium Carbonate, CrudeACTIVE INGREDIENT2E32821G6I1
PodophyllumACTIVE INGREDIENT2S713A4VP31
Rheum Officinale RootACTIVE INGREDIENTA47JP5ZG9M1
Scutellaria LaterifloraACTIVE INGREDIENT7BP4DH5PDC1
Silicon DioxideACTIVE INGREDIENTETJ7Z6XBU41
Sodium BorateACTIVE INGREDIENT91MBZ8H3QO1
Strychnos Nux-vomica SeedACTIVE INGREDIENT269XH139191
Tribasic Calcium PhosphateACTIVE INGREDIENT91D9GV0Z281
Turpentine OilACTIVE INGREDIENTC5H0QJ6V7F1
ValerianACTIVE INGREDIENTJWF5YAW3QW1
Wood CreosoteACTIVE INGREDIENT3JYG22FD731
Aconitum NapellusACTIVE MOIETYU0NQ8555JD1
Apis MelliferaACTIVE MOIETY7S82P3R43Z1
Arabica Coffee BeanACTIVE MOIETY3SW678MX721
Atropa BelladonnaACTIVE MOIETYWQZ3G9PF0H1
Baptisia TinctoriaACTIVE MOIETY5K1UO2888Y1
Borate IonACTIVE MOIETY44OAE30D221
Bryonia Alba RootACTIVE MOIETYT7J046YI2B1
Chelidonium MajusACTIVE MOIETY7E889U5RNN1
Citrullus Colocynthis Fruit PulpACTIVE MOIETY23H32AOH171
Collinsonia Canadensis RootACTIVE MOIETYO2630F3XDR1
GingerACTIVE MOIETYC5529G5JPQ1
Magnesium CationACTIVE MOIETYT6V3LHY8381
Matricaria RecutitaACTIVE MOIETYG0R4UBI2ZZ1
Oyster Shell Calcium Carbonate, CrudeACTIVE MOIETY2E32821G6I1
Phosphate IonACTIVE MOIETYNK08V8K8HR1
PodophyllumACTIVE MOIETY2S713A4VP31
Rheum Officinale RootACTIVE MOIETYA47JP5ZG9M1
Scutellaria LaterifloraACTIVE MOIETY7BP4DH5PDC1
Silicon DioxideACTIVE MOIETYETJ7Z6XBU41
Strychnos Nux-vomica SeedACTIVE MOIETY269XH139191
Turpentine OilACTIVE MOIETYC5H0QJ6V7F1
ValerianACTIVE MOIETYJWF5YAW3QW1
Wood CreosoteACTIVE MOIETY3JYG22FD731
AlcoholINACTIVE INGREDIENT3K9958V90M1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-150955714-1509-1, 55714-1509-2, 55714-1509-0

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
Aconitum NapellusU0NQ8555JDACTIB
Apis Mellifera7S82P3R43ZACTIB
Baptisia Tinctoria5K1UO2888YACTIB
Atropa BelladonnaWQZ3G9PF0HACTIB
Sodium Borate91MBZ8H3QOACTIB
Bryonia Alba RootT7J046YI2BACTIB
Oyster Shell Calcium Carbonate, Crude2E32821G6IACTIB
Tribasic Calcium Phosphate91D9GV0Z28ACTIB
Matricaria RecutitaG0R4UBI2ZZACTIB
Chelidonium Majus7E889U5RNNACTIB
Arabica Coffee Bean3SW678MX72ACTIB
Collinsonia Canadensis RootO2630F3XDRACTIB
Citrullus Colocynthis Fruit Pulp23H32AOH17ACTIB
Wood Creosote3JYG22FD73ACTIB
Magnesium Phosphate, Dibasic TrihydrateHF539G9L3QACTIB
Strychnos Nux-vomica Seed269XH13919ACTIB
Podophyllum2S713A4VP3ACTIB
Rheum Officinale RootA47JP5ZG9MACTIB
Scutellaria Lateriflora7BP4DH5PDCACTIB
Silicon DioxideETJ7Z6XBU4ACTIB
Turpentine OilC5H0QJ6V7FACTIB
GingerC5529G5JPQACTIB
ValerianJWF5YAW3QWACTIB
Alcohol3K9958V90MIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 59 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
AlcoholALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates

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
eb10e98e-a6c0-5815-f9ab-fb5b366db85b5484d315-d121-77ff-0445-16cbad3f078e2011-03-01WarningsExact identifier
spl id: eb10e98e-a6c0-5815-f9ab-fb5b366db85b
spl set id: 5484d315-d121-77ff-0445-16cbad3f078e

Reported adverse events (FAERS/openFDA)#

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