Pediatric Earache Remedy
- Product NDC
- 64616-050
- 11-digit product format
- 646160050
- Labeler code
- 64616
- Product ID
- 64616-050_462ed52e-9da2-6cc3-e063-6294a90ad318
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ear Drops
- Dosage form
- LIQUID
- Route
- AURICULAR (OTIC)
- Labeler
- Vitality Works, Inc
- Marketing category
- UNAPPROVED HOMEOPATHIC
- Marketing start
- 2006-10-23
- Substance
- ACONITUM NAPELLUS; ATROPA BELLADONNA; MATRICARIA RECUTITA; PLANTAGO MAJOR; POTASSIUM CHLORIDE; VERBASCUM THAPSUS
- Active strength
- 6; 3; 6; 3; 3; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
- Pharmacologic classes
- Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Pediatric Earache Remedy
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACONITUM NAPELLUS | 6 [hp_X]/mL |
| ATROPA BELLADONNA | 3 [hp_X]/mL |
| MATRICARIA RECUTITA | 6 [hp_X]/mL |
| PLANTAGO MAJOR | 3 [hp_X]/mL |
| POTASSIUM CHLORIDE | 3 [hp_X]/mL |
| VERBASCUM THAPSUS | 6 [hp_X]/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U0NQ8555JD, WQZ3G9PF0H, G0R4UBI2ZZ, W2469WNO6U, 660YQ98I10, C9TD27U172 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 64616-050-01 | Pediatric Earache Remedy | 15 mL in 1 BOTTLE, DROPPER | LIQUID | 15 | | 9 |
| 64616-050-02 | Pediatric Earache Remedy | 1 in 1 CARTON | LIQUID | 1 | | 9 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ACONITUM NAPELLUS | ACTIVE INGREDIENT | U0NQ8555JD | PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC] | 1 | |
| ATROPA BELLADONNA | ACTIVE INGREDIENT | WQZ3G9PF0H | PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC] | 1 | |
| MATRICARIA RECUTITA | ACTIVE INGREDIENT | G0R4UBI2ZZ | PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC] | 1 | |
| PLANTAGO MAJOR | ACTIVE INGREDIENT | W2469WNO6U | PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC] | 1 | |
| POTASSIUM CHLORIDE | ACTIVE INGREDIENT | 660YQ98I10 | PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC] | 1 | |
| VERBASCUM THAPSUS | ACTIVE INGREDIENT | C9TD27U172 | PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC] | 1 | |
| ACONITUM NAPELLUS | ACTIVE MOIETY | U0NQ8555JD | PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC] | 1 | |
| ATROPA BELLADONNA | ACTIVE MOIETY | WQZ3G9PF0H | PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC] | 1 | |
| MATRICARIA RECUTITA | ACTIVE MOIETY | G0R4UBI2ZZ | PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC] | 1 | |
| PLANTAGO MAJOR | ACTIVE MOIETY | W2469WNO6U | PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC] | 1 | |
| POTASSIUM CATION | ACTIVE MOIETY | 295O53K152 | PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC] | 1 | |
| VERBASCUM THAPSUS | ACTIVE MOIETY | C9TD27U172 | PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC] | 1 | |
| CITRUS PARADISI SEED | INACTIVE INGREDIENT | 12F08874Y7 | PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC] | 1 | |
| OLEA EUROPAEA LEAF | INACTIVE INGREDIENT | MJ95C3OH47 | PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64616-050 | PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC] | 8 | Current NDC, Legacy NDC, 2 package rows | 20241212_5769ce2c-d2e1-4069-92cc-e38bee668daf.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 64616-050-01 | 64616005001 | 15 mL in 1 BOTTLE, DROPPER | 15 ml | | | | | Historical |
| 64616-050-02 | 64616005002 | 1 BOTTLE, DROPPER in 1 CARTON (64616-050-02) / 15 mL in 1 BOTTLE, DROPPER (64616-050-01) | | 2007-07-30 | 0000-00-00 | No | No | Current |