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 136 of 160 · 3,195 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hevert Detox LymphARSENIC TRIOXIDE, CLEMATIS RECTA FLOWERING TOP, CONIUM MACULATUM FLOWERING TOP, LACHESIS MUTA VENOM, MERCURIC IODIDE, PHYTOLACCA AMERICANA ROOT, TOXICODENDRON PUBESCENS SHOOT, SCROPHULARIA NODOSA LEAF WITH STEM, AND SULFURHevert Arzneimittel GmbH & Co KG02661e24-1270-4b5b-9a62-ca156015f33c2022-12-20WarningsExact identifier
unii: 70FD1KFU70
SODIUM CHLORIDESODIUM CHLORIDELiebel-Flarsheim Company LLCe4540d03-06b4-4b4d-b859-75c13e5c20dd2022-12-20Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
ZELLULISANARNICA MONTANA ROOT, LEDUM PALUSTRE TWIG, TOXICODENDRON PUBESCENS SHOOT, SULFUR, HORSE CHESTNUT, BETULA PENDULA LEAF, HEDERA HELIX FLOWERING TWIG, AND MELILOTUS OFFICINALIS TOPPEKANA Naturheilmittel GmbH2fe46c61-93d0-45b0-b9bd-356cd7347eb72022-12-20WarningsExact identifier
unii: 70FD1KFU70
CROUP CPACONITUM NAPELLUS, CALCAREA CARBONICA, HEPAR SULPHURIS CALCAREUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, PHOSPHORUS, PULSATILLA, SAMBUCUS NIGRA, SPONGIA TOSTA, SULPHURNatural Creations, Inc78bab8d8-0d28-449b-b9d8-dc4222ce51472022-12-19WarningsExact identifier
unii: 27YLU75U4W
unii: 70FD1KFU70
unii: I76KB35JEV
unii: 1MBW07J51Q
Cough SyrupCAMPHOR (NATURAL), ARSENIC TRIOXIDE, BRYONIA ALBA ROOT, DROSERA ROTUNDIFOLIA, IPECAC, POTASSIUM CARBONATE, PHOSPHORUS, ANEMONE PULSATILLA, SPONGIA OFFICINALIS SKELETON, ROASTED, DRIMIA MARITIMA WHOLENatural Creations, Inc.285230d6-96b7-4bab-8347-c7b10a3c0ebb2022-12-19WarningsExact identifier
unii: 27YLU75U4W
unii: I76KB35JEV
COLIC CPAETHUSA CYNAPIUM, ALUMINUM OXIDE, BRYONIA ALBA ROOT, OYSTER SHELL CALCIUM CARBONATE CRUDE, MATRICARIA RECUTITA, LYCOPODIUM CLAVATUM SPORE, PHOSPHORUS, ANEMONE PULSATILLA, SILICON DIOXIDE, SULFUR.Natural Creations, Inc.7c2a2f6e-a332-4c68-a7a8-fdc390f1827e2022-12-19WarningsExact identifier
unii: 27YLU75U4W
unii: 70FD1KFU70
unii: G0R4UBI2ZZ
unii: I76KB35JEV
WartsANTIMON. CRUD., BRYONIA, CALC.CARB., CAUSTICUM, DULCAMARA, GRAPHITES, LYCOPODIUM, MERC. SULPH. RUB., NAT. CARB., NITRICUM AC., NUX VOM., RHUS TOXICODENDRON, SABINA, SEPIA, SILICEA, STAPHYSAG., SULPHUR, THUJA OCC., TARAXACUMNewton Laboratories, Inc.f0315c9e-8922-c0b5-e053-2a95a90ae54e2022-12-19WarningsExact identifier
unii: 70FD1KFU70
NATRUM MURIATICUMSODIUM CHLORIDEHyland's Inc.21ee53eb-b41a-4d2e-8037-12973d2b73d92022-12-19WarningsExact identifier
unii: 451W47IQ8X
WartsANTIMON. CRUD., BRYONIA, CALC.CARB., CAUSTICUM, DULCAMARA, GRAPHITES, LYCOPODIUM, MERC. SULPH. RUB., NAT. CARB., NITRICUM AC., NUX VOM., RHUS TOXICODENDRON, SABINA, SEPIA, SILICEA, STAPHYSAG., SULPHUR, THUJA OCC., TARAXACUMNewton Laboratories, Inc.f031e256-fca5-3939-e053-2995a90a4fe62022-12-19WarningsExact identifier
unii: 70FD1KFU70
WartsANTIMON. CRUD., BRYONIA, CALC.CARB., CAUSTICUM, DULCAMARA, GRAPHITES, LYCOPODIUM, MERC. SULPH. RUB., NAT. CARB., NITRICUM AC., NUX VOM., RHUS TOXICODENDRON, SABINA, SEPIA, SILICEA, STAPHYSAG., SULPHUR, THUJA OCC., TARAXACUMNewton Laboratories, Inc.f0328097-e5d2-3532-e053-2a95a90a93f02022-12-19WarningsExact identifier
unii: 70FD1KFU70
WartsANTIMON. CRUD., BRYONIA, CALC.CARB., CAUSTICUM, DULCAMARA, GRAPHITES, LYCOPODIUM, MERC. SULPH. RUB., NAT. CARB., NITRICUM AC., NUX VOM., RHUS TOXICODENDRON, SABINA, SEPIA, SILICEA, STAPHYSAG., SULPHUR, THUJA OCC., TARAXACUMNewton Laboratories, Inc.f032e7bb-a6fd-2951-e053-2a95a90a8c3a2022-12-19WarningsExact identifier
unii: 70FD1KFU70
Dr Talbots Infant Pain Fever ReliefCALENDULA OFFICINALIS 12X,CHAMOMILLA 12X,ECHINACEA ANGUSTIFOLIA 12X,EUPATORIUM PERFOLIATUM 12X,HEPAR SULPHURIS CALCAREUM 12X,SULPHUR 12X,FERRUM PHOSPHORICUM 12X,KALI MURIATICUM 6XTalbot's Pharmaceuticals Family Products,LLC.e881a3ce-8cf9-0ce6-e053-2995a90ae8242022-12-16WarningsExact identifier
unii: G0R4UBI2ZZ
unii: 1MBW07J51Q
CVS Health Sterile Saline MistSODIUM CHLORIDECVS Pharmacy4df47f14-8268-4cd3-b29e-96446743e2f62022-12-16WarningsExact identifier
unii: 451W47IQ8X
HABIFACFORMIC ACID, NITRIC ACID, BAPTISIA TINCTORIA ROOT, GRAPHITE, CALCIUM SULFIDE, THUJA OCCIDENTALIS LEAFY TWIG, CYNANCHUM VINCETOXICUM LEAF, AND GLECHOMA HEDERACEA FLOWERING TOPPEKANA Naturheilmittel GmbHb5fd91ae-3822-421a-a449-4178111950bc2022-12-15WarningsExact identifier
unii: 1MBW07J51Q
Cold and CoughONION, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS, SULFUR, AND GOLDENSEALWal-Mart Stores, Inc.69349b4d-6c5b-7121-e053-2991aa0a35942022-12-15WarningsExact identifier
unii: 27YLU75U4W
unii: 451W47IQ8X
unii: 492225Q21H
unii: ZW3Z11D0JV
unii: 70FD1KFU70
unii: I76KB35JEV
unii: 1MBW07J51Q
Childrens Cold and Cough NighttimeONION, CALCIUM SULFIDE, SODIUM CHLORIDE, ANEMONE PULSATILLA, ARABICA COFFEE BEAN, MATRICARIA CHAMOMILLA, SULFUR, PHOSPHORUS AND GOLDENSEALWalgreen Company80c41b65-0411-4395-e053-2a91aa0a9df92022-12-15WarningsExact identifier
unii: 27YLU75U4W
unii: 3SW678MX72
unii: 451W47IQ8X
unii: 492225Q21H
unii: ZW3Z11D0JV
unii: 70FD1KFU70
unii: G0R4UBI2ZZ
unii: I76KB35JEV
unii: 1MBW07J51Q
Childrens Cold and CoughONION, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS, SULFUR, AND GOLDENSEALWalgreen Company80b5f707-a839-7729-e053-2991aa0a1c562022-12-15WarningsExact identifier
unii: 27YLU75U4W
unii: 451W47IQ8X
unii: 492225Q21H
unii: ZW3Z11D0JV
unii: 70FD1KFU70
unii: I76KB35JEV
unii: 1MBW07J51Q
FERRODONNAARSENIC TRIOXIDE, CEANOTHUS AMERICANUS LEAF, CINCHONA OFFICINALIS BARK, COBALTOUS NITRATE, CUPRIC SULFATE, IRON, MANGANESE ACETATE, AND SODIUM CHLORIDEPEKANA Naturheilmittel GmbH64c6f75a-382d-4aa0-b210-6be83a62fa3f2022-12-14WarningsExact identifier
unii: 451W47IQ8X
SNIFFLES N SNEEZES 4 KIDSACONITUM NAPELLUS ROOT, ONION, GELSEMIUM SEMPERVIRENS ROOT, AND ZINC GLUCONATEHyland's Inc.323340a5-b493-42cd-87c6-9398cd06554e2022-12-14WarningsExact identifier
unii: 492225Q21H
Nat MurSODIUM CHLORIDEHyland's Inc.d3ab4254-daaf-24ac-e053-2995a90afb8f2022-12-13WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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