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 |
|---|---|---|---|---|---|---|
| Comfort Down There Hemorrhoids | AESCULUS HIPPOCASTANUM 5C, ALOE 5C, BERBERIS VULGARIS 3C, CAPSICUM ANNUUM 5C, CARDUUS MARIANUS 3C, NUX VOMICA 5C, PULSATILLA 9C | SEVENE USA | 55001764-8bc9-cbac-e063-6394a90a455c | 2026-08-18 | Warnings | I76KB35JEV |
| Cold Comfort Cold and Cough | ALLIUM CEPA 5C, EUPHRASIA OFFICINALIS 5C, HYDRASTIS CANADENSIS 5C, NUX VOMICA 5C, PULSATILLA 5C, RUMEX CRISPUS 5C,SABADILLA 5C, SAMBUCUS NIGRA 5C | SEVENE USA | 54e9282a-604d-4acd-e063-6394a90a59ff | 2026-08-18 | Warnings | I76KB35JEV |
| DELFLEX | DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE | Fresenius Medical Care Renal Therapies Group, LLC | bbc5b820-4973-11e2-a192-0002a5d5c51b | 2026-08-18 | Warnings, Adverse reactions | 451W47IQ8X |
| DELFLEX | DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE | Fresenius Medical Care Renal Therapies Group, LLC | c29bdfa0-4976-11e2-939b-0002a5d5c51b | 2026-08-18 | Warnings, Adverse reactions | 451W47IQ8X |
| DELFLEX | DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE | Fresenius Medical Care Renal Therapies Group, LLC | 515dcee0-3e34-11e2-a25f-0800200c9a66 | 2026-08-18 | Warnings, Adverse reactions | 451W47IQ8X |
| Leader Dry Eye Relief Eye Drops | GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400 | CARDINAL HEALTH 110, LLC. DBA LEADER | 2ded4bda-b3c3-4521-8701-5c8446fd148b | 2026-08-17 | Warnings | PDC6A3C0OX |
| BM BM63 DROPS | CEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADEN | BM Private Limited | 59006d82-610a-2e08-e063-6394a90af1ed | 2026-08-14 | Warnings | 059QF0KO0R |
| BM BM104 DROPS | CALC FLUOR, CHIMAPHILA, FERR PHOS, HYDRANGEA, KALI PHOS, SAW PALMETTO, SULPHUR | BM Private Limited | 5900caa3-e5b2-54d7-e063-6294a90adac2 | 2026-08-14 | Warnings | 70FD1KFU70 |
| BM BM134 DROPS | ARSENIC ALBUM, HYDRASTIS, MYRISTICA, NITRIC ACID, PAEONIA, RHUS TOX, SILICEA | BM Private Limited | 59023500-89be-cc76-e063-6294a90a6e02 | 2026-08-14 | Warnings | ZW3Z11D0JV |
| BM BM164 DROPS | ARUM TRYPH, CAUSTICUM, BALSAMUM PERU, HELONIAS DIO, ACID PHOS, GLYCERINUM, EQUISETUM | BM Private Limited | 5902770f-eb01-d099-e063-6394a90ad3eb | 2026-08-14 | Warnings | PDC6A3C0OX |
| BM BM125 DROPS | ARSENIC ALBUM, DOLICHOS, HEPAR SULPH, MEZEREUM, RANUNCULUS BULB, RHUS TOX | BM Private Limited | 5903117f-5278-a1bc-e063-6294a90a8f64 | 2026-08-14 | Warnings | 1MBW07J51Q |
| BM BM173 DROPS | ECHINACEA, EUPHRASIA, NATRUM MUR, RHUS TOX, SILICEA, SULPHUR, URTICA UREN | BM Private Limited | 59036ca4-e7bb-bbe7-e063-6394a90a410a | 2026-08-14 | Warnings | 451W47IQ8X 70FD1KFU70 |
| Carbo Chamomilla | CARBO CHAMOMILLA | Uriel Pharmacy Inc. | 6bc88bd3-ffe9-46d7-e053-2a91aa0acf79 | 2026-08-14 | Warnings | G0R4UBI2ZZ |
| Calm mind Stress - Nervousness - Anxiety - Concentration | ACONITUM NAPELLUS 9C, CHAMOMILLA 9C, GELSEMIUM SEMPERVIRENS 9C, IGNATIA AMARA 9C, PASSIFLORA INCARNATA 3C, STRAMONIUM 9C | SEVENE USA | 551125a8-b6ed-f9f4-e063-6294a90a4c41 | 2026-08-13 | Warnings | G0R4UBI2ZZ |
| Natural Lift Lack of energy - Fatigue | AVENA SATIVA 9C, GELSEMIUM SEMPERVIRENS 9C, PANAX GINSENG 3C, NATRUM MURIATICUM 9C | SEVENE USA | 551194c4-dfd8-c42d-e063-6294a90aecee | 2026-08-13 | Warnings | 451W47IQ8X |
| Travel Reset Jet Lag - Motion Sickness | CHAMOMILLA 9C, COCCULUS INDICUS 9C, IGNATIA AMARA 9C, IPECACUANHA 9C, LYCOPODIUM CLAVATUM 9C, TABACUM 9C | SEVENE USA | 5511dcde-f818-07c8-e063-6294a90aebfe | 2026-08-13 | Warnings | G0R4UBI2ZZ |
| BM BM53 DROPS | APIS MELLIFICA, APIUM VIRUS, ARSENIC ALB., BRYONIA ALBA, SULPHUR | BM Private Limited | 58eeb0eb-d09a-b979-e063-6394a90ad84d | 2026-08-13 | Warnings | 70FD1KFU70 |
| BM BM59 DROPS | CALC CARB, DULCAMARA, HEPAR SULPH, LYCOPODIUM, NAT MUR, SULPHUR, THUJA OCC | BM Private Limited | 58ef0755-c2cd-b7c2-e063-6294a90a2707 | 2026-08-13 | Warnings | 451W47IQ8X 70FD1KFU70 1MBW07J51Q |
| CALMS FORTE | AVENA SATIVA FLOWERING TOP, TRIBASIC CALCIUM PHOSPHATE, MATRICARIA RECUTITA, FERROSOFERRIC PHOSPHATE, HOPS, POTASSIUM PHOSPHATE, DIBASIC, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, AND PASSIFLORA INCARNATA FLOWER | Hyland's Inc. | 63ce9942-a299-4d9b-b63b-35b297472dc9 | 2026-08-13 | Warnings | G0R4UBI2ZZ |
| Spot Correction | SULFUR | HydroPeptide LLC | 45ec40ff-7134-085b-e054-00144ff8d46c | 2026-08-12 | Warnings | 70FD1KFU70 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.