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 |
|---|---|---|---|---|---|---|
| Cough - Airway | INFLUENZA A VIRUS, INFLUENZA B VIRUS, ANTIMON. TART., ARSENICUM ALB., BRYONIA, CHELIDONIUM MAJUS, CINCHONA, DROSERA, EUCALYPTUS, HISTAMINUM HYDROCHLORICUM, HYDRASTIS, KALI BIC., KALI CARB.,KALI IOD., MYRRHA, NAT. SULPHURICUM, NUX VOM., PHOSPHORUS, PULSATILLA, RUMEX CRISP., SAMBUCUS NIG., SPONGIA, TUSSILAGO FARFARA, VERBASCUM, ECHINACEA, LAPPA | Newton Laboratories, Inc. | 92ae84ae-559c-79b8-e053-2a95a90aa79f | 2022-03-17 | Warnings | 27YLU75U4W ZW3Z11D0JV I76KB35JEV |
| Cough - Airway | INFLUENZA A VIRUS, INFLUENZA B VIRUS, ANTIMON. TART., ARSENICUM ALB., BRYONIA, CHELIDONIUM MAJUS, CINCHONA, DROSERA, EUCALYPTUS, HISTAMINUM HYDROCHLORICUM, HYDRASTIS, KALI BIC., KALI CARB.,KALI IOD., MYRRHA, NAT. SULPHURICUM, NUX VOM., PHOSPHORUS, PULSATILLA, RUMEX CRISP., SAMBUCUS NIG., SPONGIA, TUSSILAGO FARFARA, VERBASCUM, ECHINACEA, LAPPA | Newton Laboratories, Inc. | 92aeb17c-8d05-a3b2-e053-2995a90a8626 | 2022-03-17 | Warnings | 27YLU75U4W ZW3Z11D0JV I76KB35JEV |
| Cold - Sinus | INFLUENZA A VIRUS, INFLUENZA B VIRUS, ARALIA QUINQUEFOLIA, ARSENICUM ALB., BRYONIA, EUPHRASIA, GAULTHERIA PROCUBENS, GELSEMIUM, HEPAR SULPH. CALC., HISTAMINUM HYDROCHLORICUM, HYDRASTIS, KALI BIC., MERC. VIV., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SABADILLA, SALVIA, STICTA, VERBASCUM, ECHINACEA | Newton Laboratories, Inc. | 7a433e80-087e-289c-e053-2a91aa0a9447 | 2022-03-17 | Warnings | 27YLU75U4W ZW3Z11D0JV I76KB35JEV 1MBW07J51Q |
| Cold - Cough | INFLUENZA A VIRUS, INFLUENZA B VIRUS, ANTIMON. TART., ARSENICUM ALB., BRYONIA, CHELIDONIUM MAJUS, CINCHONA, DROSERA, EUCALYPTUS, HISTAMINUM HYDROCHLORICUM, HYDRASTIS, KALI BIC., KALI CARB.,KALI IOD., MYRRHA, NAT. SULPHURICUM, NUX VOM., PHOSPHORUS, PULSATILLA, RUMEX CRISP., SAMBUCUS NIG., SPONGIA, TUSSILAGO FARFARA, VERBASCUM, ECHINACEA, LAPPA | Newton Laboratories, Inc. | 98e7a385-aa56-f5fe-e053-2995a90a84d3 | 2022-03-17 | Warnings | 27YLU75U4W ZW3Z11D0JV I76KB35JEV |
| Cold - Sinus | INFLUENZA A VIRUS, INFLUENZA B VIRUS, ARALIA QUINQUEFOLIA, ARSENICUM ALB., BRYONIA, EUPHRASIA, GAULTHERIA PROCUBENS, GELSEMIUM, HEPAR SULPH. CALC., HISTAMINUM HYDROCHLORICUM, HYDRASTIS, KALI BIC., MERC. VIV., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SABADILLA, SALVIA, STICTA, VERBASCUM, ECHINACEA | Newton Laboratories, Inc. | 7a40e3b3-baa7-3ce8-e053-2991aa0a4d07 | 2022-03-17 | Warnings | 27YLU75U4W ZW3Z11D0JV I76KB35JEV 1MBW07J51Q |
| Ear Care | ECHINACEA, HYDRASTIS CANADENSIS, APIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, BRYONIA, CAPSICUM ANNUUM, CAUSTICUM, CINCHONA OFFICINALIS, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI SULPHURICUM, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, MEZEREUM, PHOSPHORUS, PLANTAGO MAJOR, PULSATILLA, SILICEA, VERBASCUM THAPSUS, TELLURIUM METALLICUM, INFLUENZINUM | Newton Laboratories, Inc. | da717cf0-54af-c4e2-e053-2995a90ac97c | 2022-03-17 | Warnings | 27YLU75U4W ZW3Z11D0JV I76KB35JEV 1MBW07J51Q |
| Sodium Chloride | SODIUM CHLORIDE | B. Braun Medical Inc. | 24a08a93-df23-474b-873e-c59ec8855f9f | 2022-03-14 | Warnings, Adverse reactions | 451W47IQ8X |
| Wild Horse 777 Moisturizing Nasal | SODIUM CHLORIDE | Wild Horse 777, Inc. | b0b4dadd-11fa-3dbb-e053-2995a90a2097 | 2022-03-14 | Warnings | 451W47IQ8X |
| STRESS / FATIGUE | EPINEPHRINE, THYROID UNSPECIFIED,BOS TAURUS PITUITARY GLAND, ARSENIC TRIOXIDE, OYSTER SHELL CALCIUM CARBONATE CRUDE, CONIUM MACULATUM FLOWERING TOP, CORTISONE ACETATE, CROTALUS HORRIDUS HORRIDUS VENOM, IRON, STRYCHNOS NUX-VOMICA SEED, PHOSPHORIC ACID, PHOSPHORUS, SELENIUM, SEPIA OFFICINALIS JUICE, ZANTHOXYLUM AMERICANUM BARK | Natural Creations, Inc. | 4c28ec7f-4490-4106-8472-d94c7073c306 | 2022-03-03 | Warnings | 27YLU75U4W |
| VIRAL HP | ARSENIC TRIOXIDE, ATROPA BELLADONNA, ECHINACEA ANGUSTIFOLIA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, LYCOPODIUM CLAVATUM SPORE, PHOSPHORIC ACID, PHOSPHORUS, RANCID BEEF, TOXICODENDRON PUBESCENS LEAF | Zorex International | 1e1bed7c-4af9-4276-85a3-57ebe1d19d4b | 2022-03-03 | Warnings | 27YLU75U4W |
| SULFACETAMIDE SODIUM, SULFUR | SULFACETAMIDE SODIUM, SULFUR | KMM Pharmaceuticals, LLC | d915dae4-450a-6282-e053-2995a90ab50b | 2022-02-28 | Warnings, Adverse reactions | 70FD1KFU70 |
| Plexion | SULFACETAMIDE SODIUM, SULFUR | Eckson Labs, LLC | d91769aa-ca46-567f-e053-2a95a90a664b | 2022-02-28 | Warnings, Adverse reactions | 70FD1KFU70 |
| Sodium Chloride | SODIUM CHLORIDE | B. Braun Medical Inc. | cc14fafd-3dcd-4fc8-bdbd-6f355c375768 | 2022-02-23 | Warnings, Adverse reactions | 451W47IQ8X |
| ANIMAL ANTIGEN | FELISCATUSHAIR,BOSTAURUSHAIR,BOSTAURUSSKIN,GALLUSGALLUSFEATHER,CANISLUPUSFAMILIARISSKIN,CANISFAMILIARISHAIR,ANASPLATYRHYNCHOSFEATHER,ANSERANSERFEATHER,CAVIAPORCELLUSHAIR,CAVIAPORCELLUSSKIN,MESOCRICETUSAURATUSHAIR,MESOCRICETUSAURATUSSKIN,SUSSCROFAHAIR,SUSSCROFASKIN,EQUUSCABALLUSHAIR,EQUUSCABALLUSDANDER,MUSMUSCULUSHAIR,MUSMUSCULUASSKIN,ORYCTOLAGUSCUNICULUSSKIN,ORYCTOLAGUSCUNICULUSHAIR,OVISARIESWHOLE,MELEAGRISGALLOPAVOFEATHER,ARSENICTRIOXIDE,BLATTAORIENTALIS,STRYCHNOSNUX-VOMICASEED,PHOSPHORUS,PULSATILLA,SULFUR | Natural Creations, Inc. | 01d9c4ab-6eab-429d-b672-26d3f20b7ada | 2022-02-17 | Warnings | 27YLU75U4W 70FD1KFU70 I76KB35JEV |
| Allergy HP | ONION, AMBROSIA ARTEMISIIFOLIA, ARSENIC TRIOXIDE, ACTIVATED CHARCOAL, EUPHRASIA STRICTA, STRYCHNOS NUX-VOMICA SEED, PULSATILLA VULGARIS, SOLIDAGO VIRGAUREA FLOWERING TOP, SULFUR | Natural Creations, Inc. | 0d374e26-6a25-44d4-8133-6c4b0be8e411 | 2022-02-17 | Warnings | 492225Q21H 70FD1KFU70 I76KB35JEV |
| Sodium Chloride | SODIUM CHLORIDE | Fresenius Kabi USA, LLC | 8b44bfd3-70a4-4b47-bc7b-590f63b8cc75 | 2022-02-15 | Warnings, Adverse reactions | 451W47IQ8X |
| ACNE HP | CARBO ANIMALIS, ACTIVATED CHARCOAL, POTASSIUM DICHROMATE, SODIUM CHLORIDE, PULSATILLA VULGARIS, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, SULFUR, ZINC | Natural Creations, Inc. | b2368ab6-e233-4473-99fa-86e1fbc2a879 | 2022-02-14 | Warnings | 451W47IQ8X 70FD1KFU70 I76KB35JEV |
| ALLERGY POLLEN | GARLIC, ECHINACEA ANGUSTIFOLIA, SOLIDAGO VIRGAUREA FLOWERING TOP, TOXICODENDRON PUBESCENS LEAF, ONION, AMBROSIA ARTEMISIIFOLIA, APIS MELLIFERA, ARSENIC TRIOXIDE, ARSENIC TRIIODIDE, EUPHRASIA STRICTA, IODINE, HISTAMINE DIHYDROCHLORIDE, LYCOPODIUM CLAVATUM SPORE, MERCURIUS SOLUBILIS, STRYCHNOS NUX-VOMICA SEED, SUS SCROFA PITUITARY GLAND POSTERIOR, ANEMONE PULSATILLA, SCHOENOCAULON OFFICINALE SEED, SULFUR | Natural Creations, Inc. | bbf000a5-3528-41d7-b109-6ab9ea087d6d | 2022-02-11 | Warnings | 492225Q21H 70FD1KFU70 I76KB35JEV |
| Sodium Chloride | SODIUM CHLORIDE | Fresenius Kabi USA, LLC | f62481fd-fcdb-4be6-ac13-29c590e925c3 | 2022-02-10 | Adverse reactions | 451W47IQ8X |
| Sterile Water | WATER | American Regent, Inc. | 78b35864-4bbc-4759-a5c1-7e4f25e22932 | 2022-01-31 | Boxed warning | 059QF0KO0R |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.