NDC 54973-3375-01 - 4 Kids Cold and Cough Nighttime
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
- 54973-3375
- Requested NDC
- 54973-3375-01
- Package NDCs from labels
- 54973-3375-1, 54973-3375-2, 54973-3375-3, 54973-3375-01
- Manufacturer
- Hyland's Consumer Health Inc. | Hyland's Inc.
- Effective date
- 2025-02-06
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Hyland's Naturals Kids Cold & Cough Nighttime | Hyland's Consumer Health Inc. | Hyland's Inc. | 2025-02-06 | HUMAN OTC DRUG LABEL |
| Hyland's Naturals Kids Cold 'n Cough Combo Pack | Hyland’s Inc. | Hyland's Inc. | 2023-09-27 | HUMAN OTC DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 54973-3375-1 | 4 Kids Cold and Cough Nighttime | 1 in 1 CARTON | LIQUID | 1 | 11 | |
| 54973-3375-1 | 4 Kids Cold and Cough Nighttime | 118 mL in 1 BOTTLE, PLASTIC | LIQUID | 118 | 11 | |
| 54973-3375-2 | 4 Kids Cold and Cough Nighttime | 5 mL in 1 PACKET | LIQUID | 5 | 11 | |
| 54973-3375-3 | 4 Kids Cold and Cough Nighttime | 1 in 1 CARTON | LIQUID | 1 | 11 | |
| 54973-3375-3 | 4 Kids Cold and Cough Nighttime | 148 mL in 1 BOTTLE, PLASTIC | LIQUID | 148 | 11 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 54973-3375 | 4 KIDS COLD AND COUGH NIGHTTIME (ONION, CALCIUM SULFIDE, SODIUM CHLORIDE, ANEMONE PULSATILLA, ARABICA COFFEE BEAN, MATRICARIA CHAMOMILLA, SULFUR, PHOSPHORUS AND GOLDENSEAL) LIQUID [HYLAND'S CONSUMER HEALTH INC.] | 11 | Current NDC, Legacy NDC, 5 package rows | 20250209_71e93027-33c9-6147-e053-2a95a90aaa09.zip |
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 |
|---|---|---|---|---|---|---|
| Sodium Chloride | SODIUM CHLORIDE | Fresenius Kabi USA, LLC | 51da05ce-e3c4-4ef5-a845-dc869152e17f | 2022-10-24 | Warnings, Adverse reactions | 451W47IQ8X |
| Eye wash | PURIFIED WATER | McKesson | bd089fde-24ba-4de5-e053-2995a90a39bb | 2022-10-18 | Warnings | 059QF0KO0R |
| Bach Original Flower Remedies Rock Water | WATER | Nelson Bach USA Limited | ea242559-1618-3354-e053-2a95a90a1a95 | 2022-10-03 | Warnings | 059QF0KO0R |
| Hydrastis Canadensis | HYDRASTIS CANADENSIS | Hahnemann Laboratories, INC. | ea2cc59f-448f-22f8-e053-2995a90a4a30 | 2022-10-03 | ZW3Z11D0JV | |
| Dr Talbots Infgant Gas Colic Relief | CARBO VEGETABILIS 12X,CHAMOMILLA 12X,FOENICULUM VULGARE 12X,LYCOPODIUM 30X,NUX MOSCHATA 12X,RAPHANUS SATIVUS 12X,ZINGIBER OFFICINALE 12X,KALI MURIATICUM 6X,MAGNESIA PHOSPHORICA 12X,NATRUM PHOSPHORICUM 6X | Talbot's Pharmaceuticals Family Products,LLC. | e8bee190-04b2-4be6-e053-2a95a90a30a0 | 2022-09-28 | Warnings | G0R4UBI2ZZ |
| Dr Talbots Infant Tummy Ache Relief | CALENDULA OFFICINALIS 12X,CARBO VEGETABILIS 12X,LYCOPODIUM 30X,FOENICULUM VULGARE 12X,NUX MOSCHATA 12X,ZINGIBER OFFICINALE 12X,KALI MURIATICUM 6X,MAGNESIA PHOSPHORICA 12X,NATRUM PHOSPHORICUM 6X | Talbot's Pharmaceuticals Family Products,LLC. | e9c24994-b935-36e6-e053-2a95a90a78df | 2022-09-28 | Warnings | G0R4UBI2ZZ |
| REFRESH OPTIVE | CARBOXYMETHYLCELLULOSE SODIUM AND GLYCERIN | Allergan, Inc. | 7f8d88af-fd3b-4138-af61-f24c59ccebd7 | 2022-09-23 | Warnings | PDC6A3C0OX |
| Sterile Water | WATER | Medical Purchasing Solutions, LLC | e90b47e3-9636-b9ee-e053-2a95a90ad48c | 2022-09-19 | Warnings, Adverse reactions | 059QF0KO0R |
| REFRESH OPTIVE Advanced | CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80 | Allergan, Inc. | ebd0839e-2e1d-4e0e-986c-19f1f5c76358 | 2022-09-15 | Warnings | PDC6A3C0OX |
| Dr Talbots Infant Mucus Cold Relief | EUPATORIUM PERF 12X,HEPAR SULPHURIS CALCAREUM 12X,KALI BICHROMICUM 12X,MARRUBIUM VULGARE 12X,PHOSPHORUS 30X,PULSATILLA 12X,RUMEX CRISPUS 12X,SAMBUCUS NIGRA 12X,CALCAREA SULPHURICA 12X,FERRUM PHOSPHORICUM 12X | Talbots Pharmaceuticals Family Products, LLC. | e8917c54-f4c2-3427-e053-2995a90adbf2 | 2022-09-13 | Warnings | 27YLU75U4W I76KB35JEV 1MBW07J51Q |
| Dr Talbots Infant Cough Relief | ANTIMONIUM TARTARICUM 12X,DROSERA ROTUNDIFOLIA 12X,IPECACUANHA 12X,PHOSPHORUS 12X,RUMEX CRISPUS 12X,SPONGIA TOSTA 12X,STICTA PULMONARIA 12X,KALI SULPHURICUM 6X | Talbots Pharmaceuticals Family Products, LLC. | e8902c05-3303-2e0f-e053-2a95a90aa15d | 2022-09-12 | Warnings | 27YLU75U4W |
| Dr Talbots Infant Pain Inflamtion Relief | ARNICA 12X,BELLIS PERENNIS 12X,CALENDULA OFFICINALIS 12X,CHAMOMILLA 12X,COFFEA CRUDA 12X,HYPERICUM 12X,MILLEFOLIUM 12X,FERRUM PHOSPHORICUM 12X,KALI MURIATICUM 6X,MAGNESIA PHOSPHORICA 6X | Talbots Pharmaceuticals Family Products, LLC. | e892c0cb-03b4-52da-e053-2995a90a0878 | 2022-09-12 | Warnings | 3SW678MX72 G0R4UBI2ZZ |
| Dr Talbots Infant Daily Allergy Relief | ALLIUM CEPA 12X,ARALIA RACEMOSA 12X,EUPHRASIA OFFICINALIS 12X,GALPHIMIA GLAUCA 12X,HISTAMINUM HYDROCHLORICUM 12X,LUFFA OPERCULATA 12X,PULSATILLA 12X,SOLIDAGO 12X,NATRUM MURIATICUM 6X | Talbot's Pharmaceuticals Family Products,LLC. | e8bdcc8a-c947-ff5d-e053-2a95a90a3b92 | 2022-09-12 | Warnings | 451W47IQ8X 492225Q21H I76KB35JEV |
| REFRESH OPTIVE Advanced | CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, AND POLYSORBATE 80 | Allergan, Inc. | aaa943e4-7c38-4c5a-b7c0-5a656d8cafc0 | 2022-09-01 | Warnings | PDC6A3C0OX |
| Herplex | ANATHERUM MURICATUM, CLEMATIS ERECTA, MEZEREUM, PHYTOLACCA DECANDRA, RANUNCULUS BULBOSUS, RHUS TOX, THUJA OCCIDENTALIS, NATRUM MURIATICUM, SEPIA | Nashco Products LLC | 6a1322c7-7767-4569-aa22-9d2e36331283 | 2022-08-30 | Warnings | 451W47IQ8X |
| Kids Stuffy Nose and Sinus | OYSTER SHELL CALCIUM CARBONATE, CRUDE, GOLDENSEAL, POTASSIUM DICHROMATE, PULSATILLA PRATENSIS WHOLE | Hyland's Consumer Health Inc. | e7157883-6b23-b61c-e053-2995a90afdc2 | 2022-08-25 | Warnings | ZW3Z11D0JV |
| Hendel Sinus Relief | ECHINACEA PURPUREA, ANEMONE PULSATILLA, EUPATORIUM PERFOLIATUM FLOWERING, GOLDENSEAL, POTASSDICHROMATE, LUFFA OPERCULATA FRUIT, POTASSIUM IODIDE, CALCIUM SULFIDE AND MERCURIC SULFIDE | MediNatura Inc | 819425a8-b4ec-4049-95cb-187f6729dde5 | 2022-08-18 | Warnings | ZW3Z11D0JV I76KB35JEV 1MBW07J51Q |
| Kids Cold and Cough Nighttime Grape Flavor | ONION, CHAMOMILE, ARABICA COFFEE BEAN, CALCIUM SULFIDE, GOLDEN SEAL, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS TOP, SULFUR | Hyland's Consumer Health Inc. | e676dbb7-212f-47e3-e053-2995a90af4e1 | 2022-08-17 | Warnings | 27YLU75U4W 3SW678MX72 451W47IQ8X 492225Q21H ZW3Z11D0JV 70FD1KFU70 1MBW07J51Q |
| Kids Cold and Cough Daytime Grape Flavor | ONION, CALCIUM SULFIDE, GOLDEN SEAL, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS WHOLE, SULFUR | Hyland's Consumer Health Inc. | e65f14cb-5a8e-0ad5-e053-2a95a90a6f5d | 2022-08-16 | Warnings | 27YLU75U4W 451W47IQ8X 492225Q21H ZW3Z11D0JV 70FD1KFU70 I76KB35JEV 1MBW07J51Q |
| Adrenapar | ARALIA QUINQUEFOLIA, AVENA SATIVA, GLANDULA SUPRARENALIS SUIS, ARSENICUM IODATUM, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ZINCUM METALLICUM | Energique, Inc. | 06fccf1a-2a70-4f29-8864-4577e6c39d9b | 2022-08-10 | Warnings | 27YLU75U4W |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.