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 81 of 172 · 3,421 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pollen-Weeds	GINKGO BILOBA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ADRENALINUM , ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ANTIMONIUM TARTARICUM, ARSENICUM ALBUM, ARTEMISIA VULGARIS, BAPTISIA TINCTORIA, BELLIS PERENNIS, BERBERIS VULGARIS, BRYONIA, CALLUNA VULGARIS, FLOS, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, DIOSCOREA VILOSA, EUPHRASIA OFFICINALIS, FAGUS SYLVATICA, FRAXINUS AMERICANA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, KALI BICHROMICUM, KALI IODATUM, LACHESIS MUTUS, LILIUM TIGRINUM,	Newton Laboratories, Inc.	9caafbca-c8f7-d898-e053-2995a90a357a	2025-02-07	Warnings	Exact identifier unii: 492225Q21H unii: ZW3Z11D0JV unii: I76KB35JEV
Tyson 2.0 Mike Red Eye Drops For Dry High Eyes	GLYCERIN, NAPHAZOLINE HCL	Jbrands Pharma L.L.C.	288e9c85-0562-89bf-e063-6394a90a110d	2025-02-07	Warnings	Exact identifier unii: PDC6A3C0OX
Sodium Sulfacetamide, Sulfur	SULFACETAMIDE SODIUM, SULFUR	BioComp Pharma, Inc.	c735ff03-c97c-430d-a37b-5b40cf29046a	2025-02-06	Warnings, Adverse reactions	Exact identifier unii: 70FD1KFU70
Appetite - Craving Control	ANACARDIUM ORIENTALE, ANTIMON.CRUD., ARG. NIT., BERBER. VULG., BRYONIA, CHELIDONIUM MAJUS, DIGITALIS, GRAPHITES, HUMULUS,IRIS VERSICOLOR, KALI CARB., LYCOPODIUM, NAT. CARB.,NAT. SULPHURICUM, NUX VOM., PULSATILLA, RHUS. TOXICODENDRON, SCUTELLARIA LATERIFLORA, SEPIA,STRAMONIUM, CHAMOMILLA, PASSIFLORA, VALERIANA.	Newton Laboratories, Inc.	7964f0f7-7774-fac6-e053-2a91aa0a3e4a	2025-02-06	Warnings	Exact identifier unii: 269XH13919 unii: G0R4UBI2ZZ unii: I76KB35JEV
Tummy Upset	CHAMOMILLA, ECHINACEA, IRIS VERSICOLOR, RUTA GRAVEOLENS, TARAXACUM OFFICINALE, ALOE, ANGELICA SINENSIS RADIX, ANTIMONIUM , ARGENTUM NITRICUM, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BISMUTHUM METALLICUM, BRYONIA, CINCHONA OFFICINALIS, GRAPHITES, HYDRASTIS CANADENSIS, IPECACUANHA, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, MYRRHA, NATRUM CARBONICUM, NUX VOMICA, PHOSPHORUS, PULSATILLA, ZINGIBER OFFICINALE.	Newton Laboratories, Inc.	9dc307a2-4aa1-b02a-e053-2995a90a1788	2025-02-06	Warnings	Exact identifier unii: 27YLU75U4W unii: 269XH13919 unii: ZW3Z11D0JV unii: G0R4UBI2ZZ unii: I76KB35JEV
Appetite - Craving Control	ANACARDIUM ORIENTALE, ANTIMON.CRUD., ARG. NIT., BERBER. VULG., BRYONIA, CHELIDONIUM MAJUS, DIGITALIS, GRAPHITES, HUMULUS,IRIS VERSICOLOR, KALI CARB., LYCOPODIUM, NAT. CARB.,NAT. SULPHURICUM, NUX VOM., PULSATILLA, RHUS. TOXICODENDRON, SCUTELLARIA LATERIFLORA, SEPIA,STRAMONIUM, CHAMOMILLA, PASSIFLORA, VALERIANA.	Newton Laboratories, Inc.	79655acc-f059-e509-e053-2a91aa0ac488	2025-02-06	Warnings	Exact identifier unii: 269XH13919 unii: G0R4UBI2ZZ unii: I76KB35JEV
Cold Sores	ARSENICUM ALB., BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CISTUS CANADENSIS, CONIUM, CROTON, DULCAMARA, GRAPHITES, KALI BIC., LYCOPODIUM, MEZEREUM, NUX VOM., PETROLEUM, PULSATILLA, RANUNC. BULB., RHUS TOXICODENDRON, SARSAPARILLA, SEPIA, SULPHUR, THUJA OCC., ECHINACEA, HYPERICUM	Newton Laboratories, Inc.	9b952b77-d172-1828-e053-2a95a90ab4f6	2025-02-06	Warnings	Exact identifier unii: 269XH13919 unii: 70FD1KFU70 unii: I76KB35JEV
Dairy-Grain-Nightshades	IRIS VERS., SOLIDAGO, ANTIMON. CRUD., ARG. NIT., ARSENICUM ALB., AVENA, BAPTISIA, BELLADONNA, BRYONIA, CAPSICUM, CARDUUS BEN., CINCHONA, DULCAMARA, FAGOPYRUM, GELSEMIUM, HYOSCYAMUS, IPECAC., LAC VAC., LACHESIS, LYCOPODIUM, NAT. MUR., PHOS., PODOPH. PELT., PULSATILLA, RHUS TOX., SAC. LAC., SECALE, SEPIA, STRAMONIUM, TABACUM, TRITICUM, USTILAGO MAIDIS, VERBASCUM, LYCOPERSICUM, SOLANUM NIG., SOLANUM TUB., STIGMATA, TORULA CEREVISIAE.	Newton Laboratories, Inc.	9ba83c60-35be-181a-e053-2a95a90a9895	2025-02-06	Warnings	Exact identifier unii: 27YLU75U4W unii: 451W47IQ8X unii: I76KB35JEV
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.	9bb84bae-9019-ed76-e053-2a95a90a5c3e	2025-02-06	Warnings	Exact identifier unii: 269XH13919
Eczema - Skin Care	ANTIMON. CRUD., ARSENICUM ALB., BERBER. VULG., BOVISTA, BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CROTON, DULCAMARA, GRAPHITES, HEPAR SULPH. CALC., LYCOPODIUM, MEZEREUM, NUX VOM., PETROLEUM, PULEX IRRITANS, PULSATILLA, RHUS TOXICODENDRON, SARSAPARILLA, SEPIA, SULPHUR IOD., ECHINACEA, RUMEX CRISP., TARAXACUM, URTICA UR.	Newton Laboratories, Inc.	91d5dd26-ec17-3192-e053-2a95a90a2080	2025-02-06	Warnings	Exact identifier unii: 269XH13919 unii: I76KB35JEV unii: 1MBW07J51Q
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.	9ba993f4-97af-4119-e053-2995a90a126d	2025-02-06	Warnings	Exact identifier unii: 269XH13919
Ear Wax Build-Up	ELAPS CORALLINUS, ALUMINA, CARBO VEG., CAUSTICUM, CONIUM, GRAPHITES, KALI BIC.,KALI MUR., LACHESIS, LYCOPODIUM, PETROLEUM, PULSATILLA, SABADILLA, SEPIA, SILICEA, SPONGIA, VERBASCUM, VIOLA ODORATA	Newton Laboratories, Inc.	9302b838-6003-ba6a-e053-2995a90aedd3	2025-02-06	Warnings	Exact identifier unii: I76KB35JEV
Fever - Infection	ANTHRACINUM, INFLUENZA A VIRUS, INFLUENZA B VIRUS, PYROGENIUM, ACONITUM NAP., ANTIMON. TART., ARNICA, ARSENICUM ALB., BAPTISIA, BELLADONNA, BRYONIA, CANTHARIS, CHAMOMILLA, CINCHONA, EUPATORIUM PERF., FERRUM METALLICUM, GELSEMIUM, HEPAR SULPH.CALC., IODIUM, LACHESIS, MERC. VIV., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SALIX NIGRA, VERBASCUM, APIS MEL., ECHINACEA, HYDRASTIS	Newton Laboratories, Inc.	8f023019-5c58-e0de-e053-2a95a90accfd	2025-02-06	Warnings	Exact identifier unii: 27YLU75U4W unii: ZW3Z11D0JV unii: G0R4UBI2ZZ unii: I76KB35JEV unii: 1MBW07J51Q
Fever - Infection	ANTHRACINUM, INFLUENZA A VIRUS, INFLUENZA B VIRUS, PYROGENIUM, ACONITUM NAP., ANTIMON. TART., ARNICA, ARSENICUM ALB., BAPTISIA, BELLADONNA, BRYONIA, CANTHARIS, CHAMOMILLA, CINCHONA, EUPATORIUM PERF., FERRUM METALLICUM, GELSEMIUM, HEPAR SULPH.CALC., IODIUM, LACHESIS, MERC. VIV., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SALIX NIGRA, VERBASCUM, APIS MEL., ECHINACEA, HYDRASTIS	Newton Laboratories, Inc.	91e5f7cb-9055-4708-e053-2995a90abdfa	2025-02-06	Warnings	Exact identifier unii: 27YLU75U4W unii: ZW3Z11D0JV unii: G0R4UBI2ZZ unii: I76KB35JEV unii: 1MBW07J51Q
Hangover Help	AGARICUS MUSC., ARSENICUM ALB., BISMUTHUM METALLICUM, BRYONIA, CAPSICUM, CARBO VEG., GLONOINUM, IPECAC., IRIS VERSICOLOR, LAUROCERASUS, LYCOPODIUM, MEZEREUM, NUX VOM., PULSATILLA, RANUNC. BULB. , THERIDION, VERATRUM ALB., ZINC. MET., ZINGIBER, CHAMOMILLA, PASSIFLORA, VALERIANA	Newton Laboratories, Inc.	9bcce2ee-42c2-29cf-e053-2a95a90a3639	2025-02-06	Warnings	Exact identifier unii: 269XH13919 unii: G0R4UBI2ZZ unii: I76KB35JEV
Heavy Metal Detox	ALLIUM SATIVUM, ALUMINIUM METALLICUM, ARG. MET., AUR. MET., BARYTA CARB., BERYLLIUM METALLICUM, BISMUTHUM METALLICUM, CADMIUM METALLICUM, CALC. FLUOR., CARBO VEG., CHELIDONIUM MAJUS, CINCHONA, COBALTUM MET., CUPRUM MET., GLYCYRRHIZA GLABRA, HYDROFLUORICUM ACIDUM, IRIS VERSICOLOR, MANGANUM METALLICUM, MERC. VIV., NICCOLUM METALLICUM, OSMIUM METALLICUM, PLATINUM MET., PLUMB. MET., STANNUM MET., STRONTIUM CARB., THALLIUM METALLICUM, TITANIUM METALLICUM, CARDUUS MAR., TARAXACUM	Newton Laboratories, Inc.	9bd05208-1d6e-ab85-e053-2a95a90af38e	2025-02-06	Warnings	Exact identifier unii: 2788Z9758H
Heavy Metal Detox	ALLIUM SATIVUM, ALUMINIUM METALLICUM, ARG. MET., AUR. MET., BARYTA CARB., BERYLLIUM METALLICUM, BISMUTHUM METALLICUM, CADMIUM METALLICUM, CALC. FLUOR., CARBO VEG., CHELIDONIUM MAJUS, CINCHONA, COBALTUM MET., CUPRUM MET., GLYCYRRHIZA GLABRA, HYDROFLUORICUM ACIDUM, IRIS VERSICOLOR, MANGANUM METALLICUM, MERC. VIV., NICCOLUM METALLICUM, OSMIUM METALLICUM, PLATINUM MET., PLUMB. MET., STANNUM MET., STRONTIUM CARB., THALLIUM METALLICUM, TITANIUM METALLICUM, CARDUUS MAR., TARAXACUM	Newton Laboratories, Inc.	9c07cc66-6a78-770a-e053-2a95a90a585c	2025-02-06	Warnings	Exact identifier unii: 2788Z9758H
Hives-Rashes	ANTIMON. CRUD., APIS MEL., ARSENICUM ALB., BERBER. VULG., BOVISTA, BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CROTON, DULCAMARA, GRAPHITES, HISTAMINUM HYDROCHLORICUM, LYCOPODIUM, MEZEREUM, NUX VOM., PETROLEUM, PULEX IRRITANS, PULSATILLA, RHUS TOXICODENDRON, SARSAPARILLA, SULPHUR, ECHINACEA, RUMEX CRISP., TARAXACUM, URTICA UR.	Newton Laboratories, Inc.	9c0a4d52-7d10-cc3b-e053-2a95a90a6697	2025-02-06	Warnings	Exact identifier unii: 269XH13919 unii: 70FD1KFU70 unii: I76KB35JEV
Hives-Rashes	ANTIMON. CRUD., APIS MEL., ARSENICUM ALB., BERBER. VULG., BOVISTA, BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CROTON, DULCAMARA, GRAPHITES, HISTAMINUM HYDROCHLORICUM, LYCOPODIUM, MEZEREUM, NUX VOM., PETROLEUM, PULEX IRRITANS, PULSATILLA, RHUS TOXICODENDRON, SARSAPARILLA, SULPHUR, ECHINACEA, RUMEX CRISP., TARAXACUM, URTICA UR.	Newton Laboratories, Inc.	9c0a9375-d5f7-fe71-e053-2995a90a13b6	2025-02-06	Warnings	Exact identifier unii: 269XH13919 unii: 70FD1KFU70 unii: I76KB35JEV
4 Kids Cold and Cough Nighttime	ONION, CALCIUM SULFIDE, SODIUM CHLORIDE, ANEMONE PULSATILLA, ARABICA COFFEE BEAN, MATRICARIA CHAMOMILLA, SULFUR, PHOSPHORUS AND GOLDENSEAL	Hyland's Consumer Health Inc.	71e93027-33c9-6147-e053-2a95a90aaa09	2025-02-06	Warnings	Exact identifier unii: 27YLU75U4W unii: 3SW678MX72 unii: 451W47IQ8X unii: 492225Q21H unii: ZW3Z11D0JV unii: 70FD1KFU70 unii: G0R4UBI2ZZ unii: I76KB35JEV unii: 1MBW07J51Q

Reported adverse events (FAERS/openFDA)#

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