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 table
LabelManufacturerEffective dateType
Hyland's Naturals Kids Cold & Cough NighttimeHyland's Consumer Health Inc. | Hyland's Inc.2025-02-06HUMAN OTC DRUG LABEL
Hyland's Naturals Kids Cold 'n Cough Combo PackHyland’s Inc. | Hyland's Inc.2023-09-27HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54973-3375-14 Kids Cold and Cough Nighttime1 in 1 CARTONLIQUID111
54973-3375-14 Kids Cold and Cough Nighttime118 mL in 1 BOTTLE, PLASTICLIQUID11811
54973-3375-24 Kids Cold and Cough Nighttime5 mL in 1 PACKETLIQUID511
54973-3375-34 Kids Cold and Cough Nighttime1 in 1 CARTONLIQUID111
54973-3375-34 Kids Cold and Cough Nighttime148 mL in 1 BOTTLE, PLASTICLIQUID14811

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-33754 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.]11Current NDC, Legacy NDC, 5 package rows20250209_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.

Matched openFDA labels page 153 of 160 · 3,181 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bladder - KidneyAPIS MEL., BERBER. VULG., BRYONIA, CANTHARIS, CINCHONA, EQUISETUM HYEMALE, FERRUM PHOSPHORICUM, GELSEMIUM, JUNIPERUS COM., PAREIRA, PHOSPHORUS, PLANTAGO, PULSATILLA, SABAL, TEREBINTHINA, UVA-URSI, ECHINACEA, HYDRASTIS, LAPPA, SOLIDAGONewton Laboratories, Inc.7965a320-2976-284f-e053-2991aa0a15292020-11-24WarningsExact identifier
unii: 27YLU75U4W
unii: ZW3Z11D0JV
unii: I76KB35JEV
Bladder - KidneyAPIS MEL., BERBER. VULG., BRYONIA, CANTHARIS, CINCHONA, EQUISETUM HYEMALE, FERRUM PHOSPHORICUM, GELSEMIUM, JUNIPERUS COM., PAREIRA, PHOSPHORUS, PLANTAGO, PULSATILLA, SABAL, TEREBINTHINA, UVA-URSI, ECHINACEA, HYDRASTIS, LAPPA, SOLIDAGONewton Laboratories, Inc.7975c982-87a5-dee2-e053-2a91aa0a11372020-11-24WarningsExact identifier
unii: 27YLU75U4W
unii: ZW3Z11D0JV
unii: I76KB35JEV
Blues - Mood - EmotionsANGELICA SINENSIS RADIX, ARALIA QUINQUEFOLIA, ARG. NIT., ARSENICUM ALB., BERBER. AQUI., CAPSICUM , CINCHONA, DIGITALIS, GELSEMIUM, HYPERICUM, IGNATIA, IODIUM, KALI BROM., KALI CARB., MAG. PHOS., NAT. CARB., NAT. MUR., PHOSPHORUS, SALIX NIGRA, SANGUINARIA, SEPIA, STRAMONIUM, ECHINACEA, GINKGONewton Laboratories, Inc.79890e75-dfac-0262-e053-2a91aa0a5ce52020-11-24WarningsExact identifier
unii: 27YLU75U4W
unii: 451W47IQ8X
Blues - Mood - EmotionsANGELICA SINENSIS RADIX, ARALIA QUINQUEFOLIA, ARG. NIT., ARSENICUM ALB., BERBER. AQUI., CAPSICUM , CINCHONA, DIGITALIS, GELSEMIUM, HYPERICUM, IGNATIA, IODIUM, KALI BROM., KALI CARB., MAG. PHOS., NAT. CARB., NAT. MUR., PHOSPHORUS, SALIX NIGRA, SANGUINARIA, SEPIA, STRAMONIUM, ECHINACEA, GINKGONewton Laboratories, Inc.798ab5a2-7464-8e9d-e053-2a91aa0acc982020-11-24WarningsExact identifier
unii: 27YLU75U4W
unii: 451W47IQ8X
Bowel - Digestive CareBISMUTHUM METALLICUM, ANTIMON.CRUD., ARG. NIT., ARSENICUM ALB., BAPTISIA, BRYONIA, CHAMOMILLA, CINCHONA, IRIS VERSICOLOR, KALI BIC., LACHESIS, LYCOPODIUM, MAG. CARB., NUX VOM., PHOSPHORUS, PODOPH. PELT., PULSATILLA, RAPHANUS, RHUS TOXICODENDRON, TABACUM, VERBASCUM, ZINGIBER, ECHINACEA, JUGLANS REGIA.Newton Laboratories, Inc.907fafa5-2f75-f11d-e053-2a95a90a1fb82020-11-24WarningsExact identifier
unii: 27YLU75U4W
unii: G0R4UBI2ZZ
unii: I76KB35JEV
Breast CareBUFO RANA, APIS MEL., ASTERIAS RUBENS, BELLADONNA, BRYONIA, CALC. CARB., CHAMOMILLA, CHIMAPHILA UMBELLATA, CINCHONA, CONIUM, CROTON, ECHINACEA, GRAPHITES, HELONIAS DIOICA, LACHESIS, MERC. VIV., PHELLANDRIUM AQUATICUM PHOSPHORUS, PHYTOLACCA, PULSATILLA, SANGUINARIA, SILICEA, HAMAMELIS, RUTA, TARAXACUMNewton Laboratories, Inc.79edde91-f909-f7b3-e053-2991aa0a9d1c2020-11-24WarningsExact identifier
unii: 27YLU75U4W
unii: G0R4UBI2ZZ
unii: I76KB35JEV
Cold Hands - FeetHISTAMINUM HYDROCHLORICUM,THYROIDINUM, ACONITUM NAP., ARSENICUM ALB., BRYONIA, CACTUS, CALC. FLUOR., CEANOTHUS, CINCHONA, CONVALLARIA, DIGITALIS, GELSEMIUM, GLONOINUM, HYDROCOYLE, KALI CARB., LACHESIS, NAJA, NAT CARB., NAT MUR., NUX VOM., PHOSPHORUS, PULLSATILLA, RHUS TOXICODENDRON, STROPHANTHUS HISPIDUS, SULPHUR, ECHINACEANewton Laboratories, Inc.7a2b4f28-2128-a8b2-e053-2a91aa0a24022020-11-24WarningsExact identifier
unii: 27YLU75U4W
unii: 451W47IQ8X
unii: 70FD1KFU70
unii: I76KB35JEV
ConstipationABIES NIG., AESCULUS HIPP., ALOE, ALUMINA, BRYONIA, CARBO VEG., CHELIDONIUM MAJUS, COLLINSONIA , GRAPHITES, HYDRASTIS, KALI CARB., LYCOPODIUM, MAG. MUR., MEZEREUM, NUX VOM., PODOPH. PELT., RHAMNUS PURSHIANA, SANICULA, SELENIUM, SEPIA, SILICEA, TABACUM, VERATRUM ALB., ZINC.MET., ECHINACEA, IRIS VERSICOLOR, PHYTOLACCA, TARAXACUMNewton Laboratories, Inc.90807700-3099-850c-e053-2995a90ada552020-11-24WarningsExact identifier
unii: ZW3Z11D0JV
ConstipationABIES NIG., AESCULUS HIPP., ALOE, ALUMINA, BRYONIA, CARBO VEG., CHELIDONIUM MAJUS, COLLINSONIA , GRAPHITES, HYDRASTIS, KALI CARB., LYCOPODIUM, MAG. MUR., MEZEREUM, NUX VOM., PODOPH. PELT., RHAMNUS PURSHIANA, SANICULA, SELENIUM, SEPIA, SILICEA, TABACUM, VERATRUM ALB., ZINC.MET., ECHINACEA, IRIS VERSICOLOR, PHYTOLACCA, TARAXACUMNewton Laboratories, Inc.90804a94-1e67-3ab3-e053-2a95a90aafbe2020-11-24WarningsExact identifier
unii: ZW3Z11D0JV
Post - VaccinationINFLUENZINUM, MORBILLINUM, PERTUSSINUM, ACONITUM NAP., ALUMINA, ANTIMON. TART., ARSENICUM ALB., BAPTISIA, BELLADONNA, BRYONIA, CINCHONA, CROTALUS HORRIDUS, GELSEMIUM, KALI BIC., LACHESIS, LEDUM, MERC. VIV., MEZEREUM, NUX VOM., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SILICEA, SULPHUR, THUJA OCC., VACCINIUM, APIS MEL., ECHINACEA, HYPERICUMNewton Laboratories, Inc.9042b7ad-15ed-0e81-e053-2a95a90afe282020-11-23WarningsExact identifier
unii: 27YLU75U4W
unii: 70FD1KFU70
unii: I76KB35JEV
Post-VaccinationINFLUENZINUM, MORBILLINUM, PERTUSSINUM, ACONITUM NAP., ALUMINA, ANTIMON. TART., ARSENICUM ALB., BAPTISIA, BELLADONNA, BRYONIA, CINCHONA, CROTALUS HORRIDUS, GELSEMIUM, KALI BIC., LACHESIS, LEDUM, MERC. VIV., MEZEREUM, NUX VOM., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SILICEA, SULPHUR, THUJA OCC., VACCINIUM, APIS MEL., ECHINACEA, HYPERICUMNewton Laboratories, Inc.90bb15e5-3d9d-e2e2-e053-2995a90a85ac2020-11-23WarningsExact identifier
unii: 27YLU75U4W
unii: 70FD1KFU70
unii: I76KB35JEV
Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEAsclemed USA, Inc.afac6cc5-1ced-4639-b6f6-86f40ef5c30e2020-10-29Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
GUNA ALLERGYADRENALINUM - ALLIUM CEPA - AMMONIUM CARBONICUM - APIS MELLIFICA - ARGENTUM NITRICUM - ARSENICUM ALBUM - CUPRUM ACETICUM - GALPHIMIA GLAUCA - GLANDULA SUPRARENALIS SUIS - HISTAMINUM HYDROCHLORICUM - LUFFA OPERCULATA - MATRICARIA CHAMOMILLA - MUCOSA NASALIS SUIS - NATRUM MURIATICUM - SABADILLA - SCILLA MARITIMA -Guna spaae6bd80d-2c70-1a3f-e053-2a95a90a26522020-10-23WarningsExact identifier
unii: 451W47IQ8X
unii: 492225Q21H
unii: G0R4UBI2ZZ
GUNA LYMPHO DETOXAESCULUS HIPPOCASTANUM - APIS MELLIFERA - CALENDULA OFFICINALIS FLOWER - HEXAKETOCYCLOHEXANE - EQUISETUM HYEMALE - FUMARIC ACID - GRAPHITE - HYDRASTIS CANADENSIS - HYDROCOTYLE ASIATICA - JUGLANS REGIA - LEVOTHYROXINE - MAGNESIUM PHOSPHATE - MALIC ACID - MYOSOTIS ARVENSIS - PHYTOLACCA AMERICANA ROOT - SARSAPARILLA - SODIUM DIETHYL OXALACETATE - SODIUM PYRUVATE - SUS SCROFA PLACENTA - TARAXACUM OFFICINALE -Guna spaaeb71e21-2fdb-6b84-e053-2995a90a4c012020-10-23WarningsExact identifier
unii: ZW3Z11D0JV
GUNA ARTHRO RELIEFARTERIA SUIS - ALPHA KETOGLUTARICUM ACIDUM - ALPHA LIPOICUM ACIDUM - ASCORBICUM ACIDUM - BARIUM OXALSUCCINICUM - BRYONIA ALBA - CALCAREA CARBONICA - CARTILAGO SUIS - CHLORINUM - CIMICIFUGA RACEMOSA - COLCHICUM AUTUMNALE - DULCAMARA - EMBRYO SUIS - FUNICULUS UMBILICALIS SUIS - GLANDULA SUPRARENALIS SUIS - NADIDUM - NATRUM OXALACETICUM - NATRUM SULPHURICUM - PLACENTA TOTALIS SUIS - RHUS TOXICODENDRON - SULPHUR- VENA SUIS -Guna spaaebb990a-65bc-54ed-e053-2995a90a56822020-10-23WarningsExact identifier
unii: 70FD1KFU70
Naturasil Scabies ReliefSULFUR, THUJA OCCINDENTALISNatures Innovation, Inc.6fa2c219-f0d4-43d5-a90c-75db471a8b5a2020-10-22WarningsExact identifier
unii: 70FD1KFU70
InterSolPLATELET ADDITIVE 3Fenwal, Inc.a00c4a93-cde2-4753-81f7-0d6fee9fb6902020-10-20Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
MEDULLOSSEINUM PLEXARNICA MONTANA, CALCAREA PHOSPHORICA, CALENDULA OFFICINALIS, HYPERICUM PERFORATUM, MEDULLOSSEINUM, PULSATILLA, RUTA GRAVEOLENS, SYMPHYTUM OFFICINALESeroyal USA22b7eafe-ef76-0677-e054-00144ff88e882020-10-09WarningsExact identifier
unii: I76KB35JEV
PAEONIA PlexAESCULUS HIPPOCASTANUM,ARNICA MONTANA, GRAPHITES, HAMAMELIS VIRGINIANA, NITRICUM ACIDUM, NUX VOMICA, PAEONIA OFFICINALIS, SULPHURSeroyal USA228f83c4-269c-49b3-e054-00144ff8d46c2020-10-09WarningsExact identifier
unii: 70FD1KFU70
GUNA FLAM RELIEFACONITUM NAPELLUS - APIS MELLIFERA - ARNICA MONTANA WHOLE - ATROPA BELLADONNA - BASIC CUPRIC CARBONATE - BRYONIA ALBA ROOT - MATRICARIA CHAMOMILLA WHOLE - CALCIUM SULFIDE - CITRIC ACID MONOHYDRATE - ECHINACEA ANGUSTIFOLIA - FERRIC PHOSPHATE - PHYTOLACCA AMERICANA ROOT - RANCID BEEF - SODIUM PYRUVATE - PORK LIVER - RANCID BEEF - SUS SCROFA PITUITARY GLAND -Guna spaaf5a9c74-e1c7-6574-e053-2995a90a3d102020-09-15WarningsExact identifier
unii: 2968PHW8QP
unii: G0R4UBI2ZZ
unii: 1MBW07J51Q

Reported adverse events (FAERS/openFDA)#

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