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 02:05:05
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
Contacts and useful links#
Websitewww.newtonlabs.net
www.newtonlabs.net
www.newtonlabs.netLabel 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: Children, ages 0 to 11, give 3 pellets orally (ages 12 and up, give 6 pellets) as needed or as directed by a healthcare professional. Under age 2, crush or dissolve pellets in purified water. Sensitive persons begin with 1 pellet 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: Gluten-free, non-GMO, beet-derived sucrose pellets.
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
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55714-1709-0 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-b038-f424-e053-dadaa90a57ce | Teething - Colic |
| 55714-1709-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-b038-f424-e053-dadaa90a57ce | Teething - Colic |
| 55714-1709-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-b038-f424-e053-dadaa90a57ce | Teething - Colic |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55714-1709-0 | Teething - Colic | 7.08 g in 1 BOTTLE, GLASS | PELLET | 7.08 | 1 | |
| 55714-1709-1 | Teething - Colic | 28.35 g in 1 BOTTLE, GLASS | PELLET | 28.35 | 1 | |
| 55714-1709-2 | Teething - Colic | 56.7 g in 1 BOTTLE, GLASS | PELLET | 56.7 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55714-1709 | TEETHING - 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) PELLET [NEWTON LABORATORIES, INC.] | 1 | Legacy NDC, 3 package rows | 20131022_e69eb8d8-1d4b-7b7b-20f4-900391a2fd49.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Aconitum Napellus | ACTIVE INGREDIENT | U0NQ8555JD | 1 | |
| Apis Mellifera | ACTIVE INGREDIENT | 7S82P3R43Z | 1 | |
| Arabica Coffee Bean | ACTIVE INGREDIENT | 3SW678MX72 | 1 | |
| Atropa Belladonna | ACTIVE INGREDIENT | WQZ3G9PF0H | 1 | |
| Baptisia Tinctoria | ACTIVE INGREDIENT | 5K1UO2888Y | 1 | |
| Bryonia Alba Root | ACTIVE INGREDIENT | T7J046YI2B | 1 | |
| Chelidonium Majus | ACTIVE INGREDIENT | 7E889U5RNN | 1 | |
| Citrullus Colocynthis Fruit Pulp | ACTIVE INGREDIENT | 23H32AOH17 | 1 | |
| Collinsonia Canadensis Root | ACTIVE INGREDIENT | O2630F3XDR | 1 | |
| Ginger | ACTIVE INGREDIENT | C5529G5JPQ | 1 | |
| Magnesium Phosphate, Dibasic Trihydrate | ACTIVE INGREDIENT | HF539G9L3Q | 1 | |
| Matricaria Recutita | ACTIVE INGREDIENT | G0R4UBI2ZZ | 1 | |
| Oyster Shell Calcium Carbonate, Crude | ACTIVE INGREDIENT | 2E32821G6I | 1 | |
| Podophyllum | ACTIVE INGREDIENT | 2S713A4VP3 | 1 | |
| Rheum Officinale Root | ACTIVE INGREDIENT | A47JP5ZG9M | 1 | |
| Scutellaria Lateriflora | ACTIVE INGREDIENT | 7BP4DH5PDC | 1 | |
| Silicon Dioxide | ACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| Sodium Borate | ACTIVE INGREDIENT | 91MBZ8H3QO | 1 | |
| Strychnos Nux-vomica Seed | ACTIVE INGREDIENT | 269XH13919 | 1 | |
| Tribasic Calcium Phosphate | ACTIVE INGREDIENT | 91D9GV0Z28 | 1 | |
| Turpentine Oil | ACTIVE INGREDIENT | C5H0QJ6V7F | 1 | |
| Valerian | ACTIVE INGREDIENT | JWF5YAW3QW | 1 | |
| Wood Creosote | ACTIVE INGREDIENT | 3JYG22FD73 | 1 | |
| Aconitum Napellus | ACTIVE MOIETY | U0NQ8555JD | 1 | |
| Apis Mellifera | ACTIVE MOIETY | 7S82P3R43Z | 1 | |
| Arabica Coffee Bean | ACTIVE MOIETY | 3SW678MX72 | 1 | |
| Atropa Belladonna | ACTIVE MOIETY | WQZ3G9PF0H | 1 | |
| Baptisia Tinctoria | ACTIVE MOIETY | 5K1UO2888Y | 1 | |
| Borate Ion | ACTIVE MOIETY | 44OAE30D22 | 1 | |
| Bryonia Alba Root | ACTIVE MOIETY | T7J046YI2B | 1 | |
| Calcium Cation | ACTIVE MOIETY | 2M83C4R6ZB | 1 | |
| Chelidonium Majus | ACTIVE MOIETY | 7E889U5RNN | 1 | |
| Citrullus Colocynthis Fruit Pulp | ACTIVE MOIETY | 23H32AOH17 | 1 | |
| Collinsonia Canadensis Root | ACTIVE MOIETY | O2630F3XDR | 1 | |
| Ginger | ACTIVE MOIETY | C5529G5JPQ | 1 | |
| Magnesium Cation | ACTIVE MOIETY | T6V3LHY838 | 1 | |
| Matricaria Recutita | ACTIVE MOIETY | G0R4UBI2ZZ | 1 | |
| Oyster Shell Calcium Carbonate, Crude | ACTIVE MOIETY | 2E32821G6I | 1 | |
| Podophyllum | ACTIVE MOIETY | 2S713A4VP3 | 1 | |
| Rheum Officinale Root | ACTIVE MOIETY | A47JP5ZG9M | 1 | |
| Scutellaria Lateriflora | ACTIVE MOIETY | 7BP4DH5PDC | 1 | |
| Silicon Dioxide | ACTIVE MOIETY | ETJ7Z6XBU4 | 1 | |
| Strychnos Nux-vomica Seed | ACTIVE MOIETY | 269XH13919 | 1 | |
| Turpentine Oil | ACTIVE MOIETY | C5H0QJ6V7F | 1 | |
| Valerian | ACTIVE MOIETY | JWF5YAW3QW | 1 | |
| Wood Creosote | ACTIVE MOIETY | 3JYG22FD73 | 1 | |
| Sucrose | INACTIVE INGREDIENT | C151H8M554 | 1 |
Products#
Every source-derived product name is available through these pages.
- Teething - 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
- Aconitum Napellus
- Apis Mellifera
- Baptisia Tinctoria
- Atropa Belladonna
- Sodium Borate
- Borate Ion
- Bryonia Alba Root
- Oyster Shell Calcium Carbonate, Crude
- Tribasic Calcium Phosphate
- Calcium Cation
- Matricaria Recutita
- Chelidonium Majus
- Arabica Coffee Bean
- Collinsonia Canadensis Root
- Citrullus Colocynthis Fruit Pulp
- Wood Creosote
- Magnesium Phosphate, Dibasic Trihydrate
- Magnesium Cation
- Strychnos Nux-vomica Seed
- Podophyllum
- Rheum Officinale Root
- Scutellaria Lateriflora
- Silicon Dioxide
- Turpentine Oil
- Ginger
- Valerian
- Sucrose
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55714-1709 | 55714-1709-1, 55714-1709-2, 55714-1709-0 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| Sucrose | SUCROSE | C151H8M554 | TABLET, EXTENDED RELEASE / ORAL | 284.54 mg | ||
| Sucrose | SUCROSE | C151H8M554 | CAPSULE, DELAYED RELEASE / ORAL | 955 mg | ||
| Sucrose | SUCROSE | C151H8M554 | POWDER, FOR SUSPENSION / ORAL | 40017 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, COATED / ORAL | 516.42 mg | ||
| Sucrose | SUCROSE | C151H8M554 | LOZENGE / TRANSMUCOSAL | 1255 mg | ||
| Sucrose | SUCROSE | C151H8M554 | LOZENGE / BUCCAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 119.12 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SUSPENSION/ DROPS / ORAL | 3750 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SUSPENSION, EXTENDED RELEASE / ORAL | 5400 mg | ||
| Sucrose | SUCROSE | C151H8M554 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 86 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET / BUCCAL | 109 mg | ||
| Sucrose | SUCROSE | C151H8M554 | CAPSULE, COATED PELLETS / ORAL | 59.8 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TROCHE / BUCCAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | LIQUID / ORAL | 37500 mg | ||
| Sucrose | SUCROSE | C151H8M554 | GRANULE, FOR SOLUTION / ORAL | 42596 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, SOLUTION / INTRAVENOUS | NA | ||
| Sucrose | SUCROSE | C151H8M554 | POWDER / ORAL | 27768 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SYRUP / ORAL | 46400 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET / ORAL | 4249 mg | ||
| Sucrose | SUCROSE | C151H8M554 | GRANULE, FOR SUSPENSION / ORAL | 31885 mg | ||
| Sucrose | SUCROSE | C151H8M554 | POWDER, FOR SOLUTION / ORAL | 38666 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TROCHE / ORAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | PASTILLE / ORAL | 426 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SOLUTION / RECTAL | 35.42 %w/v | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION / INTRAVENOUS | 1950 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, CHEWABLE / ORAL | 7258 mg | ||
| Sucrose | SUCROSE | C151H8M554 | CONCENTRATE / ORAL | 4800 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTABLE, LIPOSOMAL / INTRAVENOUS | 7560 mg | ||
| Sucrose | SUCROSE | C151H8M554 | CAPSULE, EXTENDED RELEASE / ORAL | 619 mg | ||
| Sucrose | SUCROSE | C151H8M554 | ELIXIR / ORAL | 18000 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | 1 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, DELAYED RELEASE / ORAL | 295.33 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 2000 mg | ||
| Sucrose | SUCROSE | C151H8M554 | DROPS / ORAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, EMULSION / INTRAVENOUS | 970 mg | ||
| Sucrose | SUCROSE | C151H8M554 | GRANULE / ORAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | SUSPENSION / ORAL | 48209 mg | ||
| Sucrose | SUCROSE | C151H8M554 | CAPSULE / ORAL | 3568 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, FILM COATED / ORAL | 145 mg | ||
| Sucrose | SUCROSE | C151H8M554 | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | 18790 mg | ||
| Sucrose | SUCROSE | C151H8M554 | WAFER / ORAL | 155.2 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SOLUTION / ORAL | 70000 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS | 9.4 %w/v | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS | 900 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS | 308 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SUPPOSITORY / RECTAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION / SUBCUTANEOUS | 47.75 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET / SUBLINGUAL | 109 mg |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 13ed5ab9-9b6e-2be1-1e67-09213578f9f0 | e69eb8d8-1d4b-7b7b-20f4-900391a2fd49 | 2011-03-01 | Warnings | 13ed5ab9-9b6e-2be1-1e67-09213578f9f0 e69eb8d8-1d4b-7b7b-20f4-900391a2fd49 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.