Indications and uses
Temporarily relieves minor pain, irritability and wakefulness associated with teething in infants.
Temporarily relieves minor pain, irritability and wakefulness associated with teething in infants.
Place 1 to 3 pellets in 1/2 teaspoon of water and allow to dissolve. After dissolving, apply immediately to child's gums. If needed, repeat every 2 hours up to 4 times per day. If preferred, mixture may be administered under the tongue. If child is persistently irritable wakeful and restless, administer 3 pellets before bed - repeat if necessary or as directed by a healthcare professional.
Active ingredients
Chamomilla (chamomile) 3X HPUS
Coffea cruda (coffee seed) 3X HPUS
Calcarea phosphorica (calcium phosphate) 12X HPUS
Chamomilla (chamomile) 3X HPUS....................irritation reliever
Coffea cruda (coffee seed) 3X HPUS..................calming aid
Calcarea phosphorica (calcium phosphate) 12X....supports dentition
Stop use and ask doctor if
Keep out of reach of children
Place 1 to 3 pellets in 1/2 teaspoon of water and allow to dissolve.
After dissolving, apply immediately to child's gums. If needed, repeat every 2 hours
up to 4 times per day. If preferred, mixture may be administered under the tongue.
If child is persistently irritable wakeful and restless, administer 3 pellets before bed
- repeat if necessary or as directed by a healthcare professional.
corn starch NF, sucrose NF (sugar)
Questions or Comments?
1-866-267-8710 or
Distributed by: Humphreys Pharmacal, Inc.
East Hampton, CT 06424
Made in USA
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bee4fa8d-8d82-423a-a0b5-40a89dd13a99 | Product name | 1 | 20250618 |
| e0d2eb29-08bd-4bba-90d1-c91c68a38767 | Product name | 4 | 20250516 |
| 30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2 | Product name | 5 | 20250304 |
| 334fe8d2-68fb-4331-a576-420e302ec069 | Product name | 7 | 20240320 |
| 444b3e50-f226-46ef-bfca-2e7035d140cd | Product name | 1 | 20190611 |
| e92765c1-be81-432a-b909-1b10777ec378 | Product name | 1 | 20190208 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| 0441a8f5-3835-497c-aedd-bc78cba56b2a | Product name | 1 | 20150317 |
| 87711080-88eb-65c5-b2dd-bf99e700a372 | Product name | 1 | 20140508 |
| ec2149b3-5c6d-5344-f757-c86411073075 | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0219-6103-00 | 2019-11-27 | C162847 | 48780-1 | 9855d018-e6cc-cd31-e053-dbdaa90ab51a | Drug Facts |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0219-6103-00 | Humphreys Baby Teething Relief Original | 1 in 1 CARTON | PELLET | 1 | 2 | |
| 0219-6103-00 | Humphreys Baby Teething Relief Original | 135 in 1 BOTTLE, PLASTIC | PELLET | 135 | 2 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0219-6103 | HUMPHREYS BABY TEETHING RELIEF ORIGINAL (MATRICARIA RECUTITA, ARABICA COFFEE BEAN, TRIBASIC CALCIUM PHOSPHATE) PELLET [HUMPHREYS PHARMACAL, INCORPORATED] | 2 | Legacy NDC, 2 package rows | 20121012_c7dfc2fc-d163-4edf-bddf-0ccb4b590dd1.zip |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| arabica coffee bean | ACTIVE INGREDIENT | 3SW678MX72 | 2 | |
| matricaria recutita | ACTIVE INGREDIENT | G0R4UBI2ZZ | 2 | |
| tribasic calcium phosphate | ACTIVE INGREDIENT | 91D9GV0Z28 | 2 | |
| arabica coffee bean | ACTIVE MOIETY | 3SW678MX72 | 2 | |
| calcium cation | ACTIVE MOIETY | 2M83C4R6ZB | 2 | |
| matricaria recutita | ACTIVE MOIETY | G0R4UBI2ZZ | 2 | |
| starch, corn | INACTIVE INGREDIENT | O8232NY3SJ | 2 | |
| sucrose | INACTIVE INGREDIENT | C151H8M554 | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0219-6103 | 0219-6103-00 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| matricaria recutita | G0R4UBI2ZZ | ACTIB |
| arabica coffee bean | 3SW678MX72 | ACTIB |
| tribasic calcium phosphate | 91D9GV0Z28 | ACTIB |
| starch, corn | O8232NY3SJ | IACT |
| sucrose | C151H8M554 | IACT |
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 | LOZENGE / TRANSMUCOSAL | 1255 mg | ||
| sucrose | SUCROSE | C151H8M554 | CONCENTRATE / ORAL | 4800 mg | ||
| sucrose | SUCROSE | C151H8M554 | SUSPENSION, EXTENDED RELEASE / ORAL | 5400 mg | ||
| sucrose | SUCROSE | C151H8M554 | TABLET, COATED / ORAL | 516.42 mg | ||
| starch, corn | STARCH, CORN | O8232NY3SJ | SUSPENSION/ DROPS / ORAL | 90 mg | ||
| starch, corn | STARCH, CORN | O8232NY3SJ | TABLET, FILM COATED / ORAL | 2000 mg | ||
| sucrose | SUCROSE | C151H8M554 | GRANULE / ORAL | NA | ||
| sucrose | SUCROSE | C151H8M554 | CAPSULE, EXTENDED RELEASE / ORAL | 619 mg | ||
| sucrose | SUCROSE | C151H8M554 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS | 308 mg | ||
| sucrose | SUCROSE | C151H8M554 | SYRUP / ORAL | 46400 mg | ||
| starch, corn | STARCH, CORN | O8232NY3SJ | TABLET / ORAL | 1116 mg | ||
| sucrose | SUCROSE | C151H8M554 | TABLET, DELAYED RELEASE / ORAL | 295.33 mg | ||
| sucrose | SUCROSE | C151H8M554 | SOLUTION / RECTAL | 35.42 %w/v | ||
| sucrose | SUCROSE | C151H8M554 | SUPPOSITORY / RECTAL | NA | ||
| starch, corn | STARCH, CORN | O8232NY3SJ | TABLET, ORALLY DISINTEGRATING / ORAL | 100 mg | ||
| starch, corn | STARCH, CORN | O8232NY3SJ | TABLET, DELAYED RELEASE / ORAL | 713 mg | ||
| sucrose | SUCROSE | C151H8M554 | CAPSULE / ORAL | 3568 mg | ||
| sucrose | SUCROSE | C151H8M554 | SUSPENSION / ORAL | 48209 mg | ||
| starch, corn | STARCH, CORN | O8232NY3SJ | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 19 mg | ||
| sucrose | SUCROSE | C151H8M554 | INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | 1 mg | ||
| starch, corn | STARCH, CORN | O8232NY3SJ | POWDER, FOR SUSPENSION / ORAL | 34 mg | ||
| starch, corn | STARCH, CORN | O8232NY3SJ | SUSPENSION, EXTENDED RELEASE / ORAL | 113 mg | ||
| starch, corn | STARCH, CORN | O8232NY3SJ | CAPSULE, DELAYED RELEASE / ORAL | 216 mg | ||
| sucrose | SUCROSE | C151H8M554 | TROCHE / BUCCAL | NA | ||
| starch, corn | STARCH, CORN | O8232NY3SJ | CONCENTRATE / ORAL | NA | ||
| starch, corn | STARCH, CORN | O8232NY3SJ | TABLET, EXTENDED RELEASE / ORAL | 184 mg | ||
| sucrose | SUCROSE | C151H8M554 | PASTILLE / ORAL | 426 mg | ||
| starch, corn | STARCH, CORN | O8232NY3SJ | CAPSULE, EXTENDED RELEASE / ORAL | 194 mg | ||
| sucrose | SUCROSE | C151H8M554 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 2000 mg | ||
| starch, corn | STARCH, CORN | O8232NY3SJ | TABLET, COATED / ORAL | 256 mg | ||
| sucrose | SUCROSE | C151H8M554 | POWDER / ORAL | 27768 mg | ||
| starch, corn | STARCH, CORN | O8232NY3SJ | SUSPENSION / ORAL | 900 mg | ||
| sucrose | SUCROSE | C151H8M554 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 119.12 mg | ||
| sucrose | SUCROSE | C151H8M554 | TABLET / ORAL | 4249 mg | ||
| sucrose | SUCROSE | C151H8M554 | INJECTION / INTRAVENOUS | 1950 mg | ||
| sucrose | SUCROSE | C151H8M554 | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | 18790 mg | ||
| sucrose | SUCROSE | C151H8M554 | POWDER, FOR SOLUTION / ORAL | 38666 mg | ||
| starch, corn | STARCH, CORN | O8232NY3SJ | DROPS / ORAL | NA | ||
| sucrose | SUCROSE | C151H8M554 | TABLET / BUCCAL | 109 mg | ||
| sucrose | SUCROSE | C151H8M554 | INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS | 900 mg | ||
| sucrose | SUCROSE | C151H8M554 | INJECTION / SUBCUTANEOUS | 47.75 mg | ||
| sucrose | SUCROSE | C151H8M554 | TROCHE / ORAL | NA | ||
| sucrose | SUCROSE | C151H8M554 | TABLET / SUBLINGUAL | 109 mg | ||
| sucrose | SUCROSE | C151H8M554 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 86 mg | ||
| starch, corn | STARCH, CORN | O8232NY3SJ | TABLET / SUBLINGUAL | 409 mg | ||
| sucrose | SUCROSE | C151H8M554 | LIQUID / ORAL | 37500 mg | ||
| sucrose | SUCROSE | C151H8M554 | ELIXIR / ORAL | 18000 mg | ||
| sucrose | SUCROSE | C151H8M554 | CAPSULE, DELAYED RELEASE / ORAL | 955 mg | ||
| starch, corn | STARCH, CORN | O8232NY3SJ | TABLET / BUCCAL | 16.6 mg | ||
| sucrose | SUCROSE | C151H8M554 | INJECTION, SOLUTION / INTRAVENOUS | NA | ||
| sucrose | SUCROSE | C151H8M554 | GRANULE, FOR SOLUTION / ORAL | 42596 mg | ||
| starch, corn | STARCH, CORN | O8232NY3SJ | PASTILLE / ORAL | NA | ||
| sucrose | SUCROSE | C151H8M554 | TABLET, EXTENDED RELEASE / ORAL | 284.54 mg | ||
| sucrose | SUCROSE | C151H8M554 | INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS | 9.4 %w/v | ||
| sucrose | SUCROSE | C151H8M554 | GRANULE, FOR SUSPENSION / ORAL | 31885 mg | ||
| starch, corn | STARCH, CORN | O8232NY3SJ | INSERT / VAGINAL | 147 mg | ||
| sucrose | SUCROSE | C151H8M554 | INJECTION, EMULSION / INTRAVENOUS | 970 mg | ||
| sucrose | SUCROSE | C151H8M554 | WAFER / ORAL | 155.2 mg | ||
| sucrose | SUCROSE | C151H8M554 | DROPS / ORAL | NA | ||
| sucrose | SUCROSE | C151H8M554 | LOZENGE / BUCCAL | NA |
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 |
|---|---|---|---|---|---|---|
| 1c039fc9-44a5-4788-a5a3-0e9d9e7d5e7e | c7dfc2fc-d163-4edf-bddf-0ccb4b590dd1 | 2012-10-11 | Warnings | 1c039fc9-44a5-4788-a5a3-0e9d9e7d5e7e c7dfc2fc-d163-4edf-bddf-0ccb4b590dd1 |
Adverse event summaries are temporarily unavailable. Other product information remains available.