NDC 64616-050-01 - Pediatric Earache Remedy
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 64616-050
- Requested NDC
- 64616-050-01
- Package NDCs from labels
- 64616-050-01, 64616-050-02
- Manufacturer
- Vitality Works, Inc | Vitality Works, Inc.
- Effective date
- 2025-12-17
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Ear Drops - Vitality Works, Inc | Vitality Works, Inc. | Vitality Works, Inc | Vitality Works, Inc. | 2025-12-17 | HUMAN OTC DRUG LABEL |
DailyMed Package Descriptions#
| 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 Dashboard NDC Coverage#
DailyMed Socrata Ingredients#
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 |
|---|---|---|---|---|---|---|
| Sterile Diluent for Treprostinil | WATER | Dr.Reddy's Laboratories Inc., | 33050ee2-519b-1f0b-d4df-9e14dd329c57 | 2021-12-23 | Warnings, Adverse reactions | 059QF0KO0R |
| Frankincense and Myrrh Neuropathy | ACONITUM NAPELLUS, BRYONIA ALBA, HYPERICUM PERFORATUM | Wise Consumer Products | 9310c00d-c60a-4e9a-b1c1-06e6bdbb24ef | 2021-12-03 | Warnings | U0NQ8555JD |
| CONSTIPATION CP | ALUMINUM OXIDE, BRYONIA ALBA ROOT, MATRICARIA RECUTITA, GRAPHITE, LYCOPODIUM CLAVATUM SPORE, STRYCHNOS NUX-VOMICA SEED, SILICON DIOXIDE, SULFUR, SODIUM CHLORIDE, MAGNESIUM CHLORIDE, LEAD, SEPIA OFFICINALIS JUICE. | Natural Creations, Inc. | 961b3ddf-41fe-46ed-b5e4-0fd8d9652edf | 2021-11-15 | Warnings | G0R4UBI2ZZ |
| Dr. Talbots Pain Fever Relief | CALENDULA OFFICINALIS, CHAMOMILLA, ECHINACEA ANGUSTIFOLIA, EUPATORIUM PERFOLIATUM, HEPAR SULPHURIS CALCAREUM, SULPHUR, FERRUM PHOSPHORICUM, KALI MURIATICUM | Talbot's Pharmaceuticals Family Products, LLC. | 91d50391-f6a7-febf-e053-2995a90a1b02 | 2021-10-05 | Warnings | 660YQ98I10 G0R4UBI2ZZ |
| Dr. Talbots Pain Inflammation Relief | ARNICA, BELLIS PERENNIS, CALENDULA OFFICINALIS, CHAMOMILLA, COFFEA CRUDA, HYPERICUM, MILLEFOLIUM, FERRUM PHOSPHORICUM, KALI MURIATICUM, MAGNESIA PHOSPHORICA | Talbot's Pharmaceuticals Family Products, LLC. | 91d57aae-7c68-cc4a-e053-2995a90aad9d | 2021-10-05 | Warnings | 660YQ98I10 G0R4UBI2ZZ |
| Dr. Talbots Gas Colic Relief | CARBO VEGETABILIS, CHAMOMILLA, FOENICULUM VULGARE, LYCOPODIUM, NUX MOSCHATA, RAPHANUS SATIVUS, ZINGIBER OFFICINALE, KALI MURIATICUM, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM | Talbot's Pharmaceuticals Family Products, LLC | 91213655-92d2-64c2-e053-2995a90aaa5a | 2021-10-05 | Warnings | 660YQ98I10 G0R4UBI2ZZ |
| Dr. Talbots Mucus Cold Relief | EUPATORIUM PERF, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MARRUBIUM VULGARE, PHOSPHORUS, PULSATILLA, RUMEX CRISPUS, SAMBUCUS NIGRA, CALCAREA SULPHURICA, FERRUM PHOSPHORICUM, KALI MURIATICUM | Talbot's Pharmaceuticals Family Products, LLC. | 91c311b2-a22c-0db0-e053-2995a90af3ef | 2021-10-05 | Warnings | 660YQ98I10 |
| Dr. Talbots Tummy Ache Relief | CALENDULA OFFICINALIS, CARBO VEGETABILIS, CHAMOMILLA, FOENICULUM VULGARE, LYCOPODIUM, NUX MOSCHATA, ZINGIBER OFFICINALE, KALI MURIATICUM, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM | Talbot's Pharmaceuticals Family Products, LLC | 91c1e0ae-9999-0ae2-e053-2995a90a2d71 | 2021-10-05 | Warnings | 660YQ98I10 G0R4UBI2ZZ |
| KALI MURIATICUM | KALI MURIATICUM | Rxhomeo Private Limited d.b.a. Rxhomeo, Inc | b70cbfef-2c00-4e13-aa88-c411c5261230 | 2021-09-29 | Warnings | 660YQ98I10 |
| ACONITUM NAPELLUS | ACONITUM NAPELLUS | Rxhomeo Private Limited d.b.a. Rxhomeo, Inc | eace2915-a54b-4649-9bd0-19461ff28dd5 | 2021-09-02 | Warnings | U0NQ8555JD |
| CHAMOMILLA | CHAMOMILLA | Rxhomeo Private Limited d.b.a. Rxhomeo, Inc | 7e21364d-0617-46a7-a03c-33c4273ecc07 | 2021-09-02 | Warnings | G0R4UBI2ZZ |
| BELLADONNA | BELLADONNA | Rxhomeo Private Limited d.b.a. Rxhomeo, Inc | f808ba4e-4421-4bc0-a2c7-42a8db8ed2e8 | 2021-08-23 | Warnings | WQZ3G9PF0H |
| Sterile Water | STERILE WATER | B. Braun Medical Inc. | d99f9133-e4d0-4dee-b611-dbc3f918b547 | 2021-08-09 | Warnings, Adverse reactions | 059QF0KO0R |
| Lactated Ringers Irrigation | SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE AND CALCIUM CHLORIDE | B. Braun Medical Inc. | 0db56c7a-2b8f-4593-8591-2c481c92b2cf | 2021-08-06 | Warnings, Adverse reactions | 660YQ98I10 |
| Sterile Water | WATER | B. Braun Medical Inc. | 8924e52e-8622-4ed6-a061-1908183e0a18 | 2021-08-06 | Warnings, Adverse reactions | 059QF0KO0R |
| Potassium Chloride | POTASSIUM CHLORIDE | Guardian Drug Company | 3d460e84-27a0-485c-8b11-58d03d9064aa | 2021-07-28 | Warnings, Adverse reactions | 660YQ98I10 |
| HFE | APIS MELLIFICA, BELLADONNA, CAULOPHYLLUM THALICTROIDES, CIMICIFUGA RACEMOSA, DIOSCOREA VILLOSA, GELSEMIUM SEMPERVIRENS, HELONIAS DIOICA, MAGNESIA PHOSPHORICA, ORYCTOLAGUS CUNICULUS (RABBIT) ADRENAL GLAND, ORYCTOLAGUS CUNICULUS (RABBIT) OVARY, ORYCTOLAGUS CUNICULUS (RABBIT) UTERUS, VIBURNUM OPULUS | Seroyal USA | 7d508fdd-ba8b-07ec-e053-2991aa0a29ef | 2021-07-22 | Warnings | WQZ3G9PF0H |
| Sleep Aid | ADENOSINUM TRIPHOSPHORICUM DINATRUM, PANTOTHENIC ACID, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, UBIDECARENONUM, L-TRYPTOPHAN, MELATONIN, PYRROLE, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, MERCURIUS CORROSIVUS, PASSIFLORA INCARNATA, SILICEA, ZINCUM VALERIANICUM, DYSENTERY BACILLUS, GAERTNER BACILLUS (BACH) | Pro Weight Loss Inc. | d0af311a-e975-4236-8c0e-0418efa7e45f | 2021-07-16 | Warnings | G0R4UBI2ZZ |
| SEPIA PLEX | ACONITUM NAPELLUS, CIMICIFUGA RACEMOSA, LACHESIS MUTUS, MELISSA OFFICINALIS, PLATINUM METALLICUM, SANGUINARIA CANADENSIS, SEPIA, SULPHURICUM ACIDUM, VALERIANA OFFICINALIS | Seroyal USA | 4c4a0a95-3848-4e19-e054-00144ff8d46c | 2021-07-15 | Warnings | U0NQ8555JD |
| Unda 3 | EQUISETUM ARVENSE STEM, CHAMOMILLA, CONDURANGO BARK, VIOLA TRICOLOR, BOLDO LEAF, ALUMINIUM METALLICUM, STANNUM METALLICUM | Seroyal USA | 1583cf73-c22c-0fa8-e054-00144ff8d46c | 2021-07-15 | Warnings | G0R4UBI2ZZ |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.