NDC 54973-3243-01 - 4 KIDS COLD N COUGH GRAPE FLAVOR

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: 54973-3243
Requested NDC: 54973-3243-01
Package NDCs from labels: 54973-3243-1, 54973-3243-2, 54973-3243-3, 54973-3243-4, 54973-3243-5, 54973-3243-01
Manufacturer: Hyland's Inc.
Effective date: 2025-12-19
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Hyland's Kids Cold & Cough Daytime Natural Grape Flavor	Hyland's Inc.	2025-12-19	HUMAN OTC DRUG LABEL
Hyland's Kids Cold 'n Cough Day & Night Combo Pack Grape Flavor	Hyland's Inc.	2025-12-19	HUMAN OTC DRUG LABEL
4 KIDS COLD N COUGH GRAPE FLAVOR - Hyland's Inc. \| Applied Laboratories, Inc	Hyland's Inc. \| Applied Laboratories, Inc	2025-02-20	HUMAN OTC DRUG LABEL
4 Kids Cold n Cough Day and Night Value Pack	Hyland's \| Standard Homeopathic Company \| Applied Laboratories, Inc.	2019-11-21	HUMAN OTC DRUG LABEL
4 Kids Cold n Cough Day and Night Combo Pack	Hyland's \| Standard Homeopathic Company \| Applied Laboratories, Inc.	2016-06-28	HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54973-3243-1	4 KIDS COLD N COUGH GRAPE FLAVOR	118 mL in 1 BOTTLE, PLASTIC	LIQUID	118		17
54973-3243-1	4 KIDS COLD N COUGH GRAPE FLAVOR	1 in 1 CARTON	LIQUID	1		17
54973-3243-2	4 KIDS COLD N COUGH GRAPE FLAVOR	236 mL in 1 BOTTLE, PLASTIC	LIQUID	236		17
54973-3243-2	4 KIDS COLD N COUGH GRAPE FLAVOR	1 in 1 CARTON	LIQUID	1		17
54973-3243-3	4 KIDS COLD N COUGH GRAPE FLAVOR	5 mL in 1 POUCH	LIQUID	5		17
54973-3243-4	4 KIDS COLD N COUGH GRAPE FLAVOR	1 in 1 CARTON	LIQUID	1		17
54973-3243-4	4 KIDS COLD N COUGH GRAPE FLAVOR	148 mL in 1 BOTTLE, PLASTIC	LIQUID	148		17
54973-3243-5	4 KIDS COLD N COUGH GRAPE FLAVOR	5 mL in 1 POUCH	LIQUID	5		17
54973-3243-1	4 Kids Cold and Cough Day and Night Grape Flavor	1 in 1 CARTON	LIQUID		6 [hp_X] in 1mL	11
54973-3243-1	4 Kids Cold and Cough Day and Night Grape Flavor	118 mL in 1 BOTTLE, PLASTIC	LIQUID	118 mL	6 [hp_X] in 1mL	11
54973-3243-1	4 Kids Cold and Cough Day and Night Grape Flavor	1 in 1 CARTON	LIQUID		6 [hp_X] in 1mL	3
54973-3243-1	4 Kids Cold and Cough Day and Night Grape Flavor	118 mL in 1 BOTTLE, PLASTIC	LIQUID	118 mL	6 [hp_X] in 1mL	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54973-3243	4 KIDS COLD N COUGH GRAPE FLAVOR (ONION, CALCIUM SULFIDE, GOLDENSEAL, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, AND SULFUR) LIQUID [HYLAND'S INC.]	15	Current NDC, Legacy NDC, 8 package rows	20240711_798e2a4d-da2d-4bbd-a9b8-574490ef7357.zip
54973-3243	4 KIDS COLD AND COUGH DAY AND NIGHT GRAPE FLAVOR (ONION,ANEMONE PULSATILLA, PHOSPHORUS, GOLDENSEAL, CALCIUM SULFIDE, SODIUM CHLORIDE, SULFUR, MATRICARIA CHAMOMILLA AND ARABICA COFFEE BEAN) KIT [HYLAND'S INC.]	7	Current NDC, Legacy NDC	20250502_79f26bb5-15ad-e40a-e053-2991aa0aaab3.zip
54973-3243	4 KIDS COLD AND COUGH DAY AND NIGHT GRAPE FLAVOR (ONION,ANEMONE PULSATILLA, PHOSPHORUS, GOLDENSEAL, CALCIUM SULFIDE, SODIUM CHLORIDE, SULFUR, MATRICARIA CHAMOMILLA AND ARABICA COFFEE BEAN) KIT [HYLAND'S INC.]	3	Current NDC, Legacy NDC	20250223_1a297e56-4cb8-75ca-e063-6294a90a592b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54973-3243-1	ML - Milliliter	54973-3243	7d28e6b8-49a4-4b0d-a073-9caf269e10c6	1	2024-06-10

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.

Matched openFDA labels page 80 of 172 · 3,435 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tobacco Withdrawal	ARSENICUM ALB., BENZOICUM ACIDUM, BERBER. VULG., BRYONIA, CALADIUM SEGUINUM, CANTHARIS, CEANOTHUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CINCHONA, DAPHNE INDICA, IGNATIA, IRIS VERSICOLOR, LYCOPODIUM, NICOTINUM, NUX VOM., RHUS TOXICODENDRON, SCUTELLARIA LATERIFLORA, TABACUM, ECHINACEA, TARAXACUM, VALERIANA	Newton Laboratories, Inc.	9d38fd5a-1657-11e5-e053-2a95a90a47ee	2025-02-10	Warnings	Exact identifier unii: 269XH13919
Teeth-Gums	CHAMOMILLA, ECHINACEA, ACONITUM NAPELLUS, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BELLADONNA, BRYONIA, CALENDULA OFFICINALIS, CHAMOMILLA, CHELIDONIUM MAJUS, CROTALUS HORRIDUS, GELSEMIUM SEMPERVIRENS, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, MERCURIUS VIVUS, MYRRHA, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PLANTAGO MAJOR, RHUS TOXICODENDRON, SILICEA, STAPHYSAGRIA	Newton Laboratories, Inc.	9d363a40-a17b-2b6f-e053-2a95a90a3384	2025-02-10	Warnings	Exact identifier unii: 27YLU75U4W unii: 269XH13919 unii: G0R4UBI2ZZ unii: 1MBW07J51Q
Tobacco Withdrawal	ARSENICUM ALB., BENZOICUM ACIDUM, BERBER. VULG., BRYONIA, CALADIUM SEGUINUM, CANTHARIS, CEANOTHUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CINCHONA, DAPHNE INDICA, IGNATIA, IRIS VERSICOLOR, LYCOPODIUM, NICOTINUM, NUX VOM., RHUS TOXICODENDRON, SCUTELLARIA LATERIFLORA, TABACUM, ECHINACEA, TARAXACUM, VALERIANA	Newton Laboratories, Inc.	9d399697-69dc-217d-e053-2a95a90a65e4	2025-02-10	Warnings	Exact identifier unii: 269XH13919
Vitality	ECHINACEA, LAPPA MAJOR, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, ADRENALINUM, ALOE, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BERBERIS AQUIFOLIUM, BERBERIS VULGARIS, BRYONIA, CHELIDONIUM MAJUS, CROTALUS HORRIDUS, DIGITALIS PURPUREA, FERRUM METALLICUM, GLONOINUM, HYDROCOTYLE ASIATICA, IODIUM, IRIS VERSICOLOR, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, THUJA OCCIDENTALIS, THYROIDINUM, GLYCYRRHIZA GLABRA	Newton Laboratories, Inc.	9d3a6b0e-a23f-9f2d-e053-2995a90a75cf	2025-02-10	Warnings	Exact identifier unii: 2788Z9758H unii: 269XH13919 unii: 451W47IQ8X
Rheumatic-Joint Care	URICUM ACIDUM, ACONITUM NAP.,APIS MEL., ARNICA, ARSENICUM ALB, BELLADONNA,BENZOICUM ACIDUM, BRYONIA, CALC. CARB., CHAMOMILLA, CINCHONA, COLCHICUM, EUPATORIUM PERF., GAULTHERIAPROCUMBENS, GUAIACUM, IODIUM, KALI BIC, KALMIA,LEDUM, PULSATILLA, RHUS TOXICODENDRON, RUTA,SABINA, STRYCHNINUM, LAPPA, PHYTOLACCA, SYMPHYTUM,	Newton Laboratories, Inc.	9cae7d07-19f5-f661-e053-2995a90a944d	2025-02-10	Warnings	Exact identifier unii: G0R4UBI2ZZ unii: I76KB35JEV
Prime	GINKGO BILOBA, RUTA GRAVEOLENS, AGNUS CASTUS, ALLIUM SATIVUM, AMBRA GRISEA, ANGELICA SINENSIS RADIX, ARALIA QUINQUEFOLIA, ARNICA MONTANA, ARSENICUM ALBUM, AVENA SATIVA, BAPTISIA TINCTORIA, BARYTA CARBONICA, BRYONIA, CANTHARIS, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PULSATILLA, RUTA GRAVEOLENS, SABAL SERRULATA, SELENIUM METALLICUM, ZINCUM METALLICUM.	Newton Laboratories, Inc.	9b40f630-0b91-9816-e053-2a95a90a16ec	2025-02-10	Warnings	Exact identifier unii: 269XH13919 unii: I76KB35JEV
Restless Leg	MYGALE, AGARICUS MUSC., CAUSTICUM, CINCHONA, CONIUM, CUPRUM MET., GELSEMIUM, HYOSCYAMUS, HYPERICUM, KALI CARB., MAG. CARB., MERC. VIV., NUX VOM., PLUMB. MET., RHUS TOXICODENDRON, SECALE, STRYCHNINUM, TARENTULA HISPANA, VALERIANA, VERBASCUM, ZINC. MET., CHAMOMILLA,PASSIFLORA	Newton Laboratories, Inc.	9b2e2194-fda3-6837-e053-2995a90ac61a	2025-02-10	Warnings	Exact identifier unii: 269XH13919 unii: G0R4UBI2ZZ
Restless Leg	MYGALE, AGARICUS MUSC., CAUSTICUM, CINCHONA, CONIUM, CUPRUM MET., GELSEMIUM, HYOSCYAMUS, HYPERICUM, KALI CARB., MAG. CARB., MERC. VIV., NUX VOM., PLUMB. MET., RHUS TOXICODENDRON, SECALE, STRYCHNINUM, TARENTULA HISPANA, VALERIANA, VERBASCUM, ZINC. MET., CHAMOMILLA,PASSIFLORA	Newton Laboratories, Inc.	9b3f076e-7edd-ea51-e053-2a95a90abd9b	2025-02-10	Warnings	Exact identifier unii: 269XH13919 unii: G0R4UBI2ZZ
Just In Case	ACONITUM NAPELLUS, ARNICA MONTANA, BRYONIA, ECHINACEA, LEDUM PALUSTRE, ARSENICUM ALBUM, CENCHRIS CONTORTRIX, CROTALUS CASCAVELLA, CROTALUS HORRIDUS, LACHESIS MUTUS, MERCURIUS CORROSIVUS, NAJA TRIPUDIANS, PHOSPHORUS, TOXICOPHIS PUGNAX, VIPERA BERUS, ELAPS CORALLINUS, HELODERMA.	Newton Laboratories, Inc.	a035f2bf-2f5d-0a50-e053-2995a90a8d9c	2025-02-10	Warnings	Exact identifier unii: 27YLU75U4W
Dust-Mold-Dander	IRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ANTIMONIUM CRUDUM, APIS MELLIFICA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BLATTA ORIENTALIS, BROMIUM, BRYONIA, CANDIDA ALBICANS, CARDUUS BENEDICTUS, CAT HAIR, CHELIDONIUM MAJUS, CINCHONA OFFICINALIS, DOG HAIR, HISTAMINUM HYDROCHLORICUM, HOUSE DUST, IPECACUANHA, LYCOPODIUM CLAVATUM, NUX VOMICA, PODOPHYLLUM PELTATUM, RHUS TOXICODENDRON, SECALE CORNUTUM, SILICEA, USTILAGO MAIDIS, TORULA CEREVISIAE.	Newton Laboratories, Inc.	99fdc906-3a55-e4c4-e053-2a95a90a76ba	2025-02-10	Warnings	Exact identifier unii: 269XH13919
Gas-Indigestion	CHAMOMILLA, ECHINACEA, IRIS VERSICOLOR, RUTA GRAVEOLENS, TARAXACUM OFFICINALE, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BRYONIA, CARBO VEGETABILIS, CHELIDONIUM MAJUS, CINCHONA OFFICINALIS, COLCHICUM AUTUMNALE, DAPHNE INDICA, IPECACUANHA, IRIS VERSICOLOR, KALI CARBONICUM, KREOSOTUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, MERCURIUS VIVUS, NUX VOMICA, PHOSPHORUS, PULSATILLA, SPIGELIA ANTHELMIA, SULPHUR, PYROGENIUM	Newton Laboratories, Inc.	9a125a53-39c2-d849-e053-2a95a90a9845	2025-02-10	Warnings	Exact identifier unii: 27YLU75U4W unii: 269XH13919 unii: 70FD1KFU70 unii: G0R4UBI2ZZ unii: I76KB35JEV
Eyesaline Eyewash Concentrate	PURIFIED WATER	Honeywell Safety Products, Inc.	2d90c8e8-f479-3535-e063-6394a90af122	2025-02-07	Warnings	Exact identifier unii: 059QF0KO0R
Leg Cramps-Swelling	ECHINACEA, ARGENTUM NITRICUM, BRYONIA, CALCAREA CARBONICA, COLOCYNTHIS, CONVALLARIA MAJALIS, CROTALUS HORRIDUS, CUPRUM METALLICUM, DIGITALIS , GELSEMIUM SEMPERVIRENS, HYPERICUM PERFORATUM, KALI CARBONICUM, LACHESIS MUTUS, LATHYRUS SATIVUS, LILIUM TIGRINUM, MAGNESIA PHOSPHORICA, NUX VOMICA, RHUS TOXICODENDRON, SILICEA, STRAMONIUM, VERATRUM VIRIDE, ELAPS	Newton Laboratories, Inc.	9c315126-e61e-f649-e053-2a95a90a7f08	2025-02-07	Warnings	Exact identifier unii: 269XH13919
Incontinence	ALOE, ARG. NIT., ARSENICUM ALB., BELLADONNA, BENZOICUM ACIDUM, BRYONIA, CANTHARIS, CAUSTICUM, EQUISETUM HYEMALE, FERRUM METALLICUM, GELSEMIUM, IGNATIA, KALI PHOS., LYCOPODIUM, NAT. MUR., NITRICUM AC., PLANTAGO, PULSATILLA, RHUS AROMATICA , SABAL, SECALE, SEPIA, STAPHYSAG.,STRAMONIUM, THYROIDINUM, VERBASCUM, ECHINACEA, HYDRASTIS	Newton Laboratories, Inc.	9c0cd92b-905d-f90f-e053-2995a90a4705	2025-02-07	Warnings	Exact identifier unii: 451W47IQ8X unii: ZW3Z11D0JV unii: I76KB35JEV
Incontinence	ALOE, ARG. NIT., ARSENICUM ALB., BELLADONNA, BENZOICUM ACIDUM, BRYONIA, CANTHARIS, CAUSTICUM, EQUISETUM HYEMALE, FERRUM METALLICUM, GELSEMIUM, IGNATIA, KALI PHOS., LYCOPODIUM, NAT. MUR., NITRICUM AC., PLANTAGO, PULSATILLA, RHUS AROMATICA , SABAL, SECALE, SEPIA, STAPHYSAG.,STRAMONIUM, THYROIDINUM, VERBASCUM, ECHINACEA, HYDRASTIS	Newton Laboratories, Inc.	9c0d8c82-6c4f-a511-e053-2995a90a793f	2025-02-07	Warnings	Exact identifier unii: 451W47IQ8X unii: ZW3Z11D0JV unii: I76KB35JEV
Lymphatic Care	ECHINACEA, SOLIDAGO, TARAXACUM, ASTERIAS, AUR. MET., BELLADONNA, BENZOICUM AC., BERBER. VULG., BRYONIA, CALC. CARB., CANTHARIS, CARDUUS MAR., CEANOTHUS, CHELIDONIUM MAJ., CHIONANTHUS, CINCHONA, DIOSCOREA, IRIS VERS., NAT. CARB., NUX VOM., PTELEA..	Newton Laboratories, Inc.	9c3507de-1def-4019-e053-2a95a90a1475	2025-02-07	Warnings	Exact identifier unii: 269XH13919
Lymphatic Care	ECHINACEA, SOLIDAGO, TARAXACUM, ASTERIAS, AUR. MET., BELLADONNA, BENZOICUM AC., BERBER. VULG., BRYONIA, CALC. CARB., CANTHARIS, CARDUUS MAR., CEANOTHUS, CHELIDONIUM MAJ., CHIONANTHUS, CINCHONA, DIOSCOREA, IRIS VERS., NAT. CARB., NUX VOM., PTELEA..	Newton Laboratories, Inc.	9c36201a-2153-0600-e053-2995a90a6bbf	2025-02-07	Warnings	Exact identifier unii: 269XH13919
Menopause	ELAPS CORALLINUS, AGNUS, ANGELICA SINENSIS RADIX, ARSENICUM ALB., BRYONIA, CANTHARIS, CAULOPHYLLUM, CIMICIFUGA, CINCHONA, CROTALUS HORRIDUS, DAMIANA, GLONOINUM, HELONIAS DIOICA, IGNATIA, KALI CARB., LACHESIS, NAJA, NUX VOM., PHOSPHORUS, PULSATILLA, SALIX NIGRA, SANGUINARIA, SEPIA, ECHINACEA, VALERIANA	Newton Laboratories, Inc.	9c4872fd-bfe5-2472-e053-2995a90a361f	2025-02-07	Warnings	Exact identifier unii: 27YLU75U4W unii: 269XH13919 unii: I76KB35JEV
Menopause	ELAPS CORALLINUS, AGNUS, ANGELICA SINENSIS RADIX, ARSENICUM ALB., BRYONIA, CANTHARIS, CAULOPHYLLUM, CIMICIFUGA, CINCHONA, CROTALUS HORRIDUS, DAMIANA, GLONOINUM, HELONIAS DIOICA, IGNATIA, KALI CARB., LACHESIS, NAJA, NUX VOM., PHOSPHORUS, PULSATILLA, SALIX NIGRA, SANGUINARIA, SEPIA, ECHINACEA, VALERIANA	Newton Laboratories, Inc.	9c4718ef-86ac-7bb7-e053-2a95a90a5627	2025-02-07	Warnings	Exact identifier unii: 27YLU75U4W unii: 269XH13919 unii: I76KB35JEV
Morning Sickness-Nausea	CHAMOMILLA, HYDRASTIS CANADENSIS, IRIS VERSICOLOR, BISMUTHUM METALLICUM, BRYONIA, CIMICIFUGA RACEMOSA, GOSSYPIUM HERBACEUM, IPECACUANHA, KREOSOTUM, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, NUX VOMICA, PULSATILLA, SEPIA, SYMPHORICARPUS RACEMOSUS, TABACUM, ZINGIBER OFFICINALE.	Newton Laboratories, Inc.	9c4a6bf8-5f48-96a8-e053-2a95a90a9757	2025-02-07	Warnings	Exact identifier unii: 269XH13919 unii: ZW3Z11D0JV unii: G0R4UBI2ZZ unii: I76KB35JEV

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.