FDA.reportPublic FDA data

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 78 of 168 · 3,349 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bestmade Natural Products BM188ALLIUM CEPA, AMBROSIA ARTEMISIA, GELSEMIUM, KALI BICHROME, NAT MUR, SABADILLABestmade Natural Products2e950192-e5cf-37b4-e063-6394a90a1e9a2025-02-20WarningsExact identifier
unii: 451W47IQ8X
unii: 492225Q21H
Bestmade Natural Products BM168CONIUM, PILOCARPINE MURIATE, KALI SIL, KALI ARS, SULPHUR, NAT MURBestmade Natural Products2e7bc230-8a37-9975-e063-6294a90a15e72025-02-19WarningsExact identifier
unii: 451W47IQ8X
unii: 70FD1KFU70
Bestmade Natural Products BM171SECALE CORN, ANTI TART, AETHUSA, TEREBINTHINA, CARBO VEG, SULPHUR, FERR METBestmade Natural Products2e7ce2b6-9eb8-30a0-e063-6294a90a73bc2025-02-19WarningsExact identifier
unii: 70FD1KFU70
Bestmade Natural Products BM172AURUM IOD, BELLADONNA, GUIACUM, HEPAR SULP, IODIUM, LAUROCERASUS, PHYTOLACCA DECBestmade Natural Products2e7d1eee-9290-17e0-e063-6394a90a9eb82025-02-19WarningsExact identifier
unii: 1MBW07J51Q
Bestmade Natural Products BM173ECHINACEA, EUPHRASIA, NATRUM MUR, RHUS TOX, SILICEA, SULPHUR, URTICA URENBestmade Natural Products2e7de086-a4c1-ae9e-e063-6394a90aa5f52025-02-19WarningsExact identifier
unii: 451W47IQ8X
unii: 70FD1KFU70
Bestmade Natural Products BM175BRYONIA, CASCARA SAG, CHELIDONIUM, CROCUS SAT, CROTON TIG, HYDRASTIS, NUX VOMICABestmade Natural Products2e7e53a3-5ae0-864a-e063-6294a90af6dc2025-02-19WarningsExact identifier
unii: ZW3Z11D0JV
Bestmade Natural Products BM176ACONITE NAP, ARS ALB, BELLADONNA, BRYONIA ALBA, CHAMOMILLA, LEDUM PAL, SULPHURBestmade Natural Products2e7e7a3c-5b60-20e2-e063-6294a90ae2892025-02-19WarningsExact identifier
unii: 70FD1KFU70
Bestmade Natural Products BM180ACONITE NAP, ARGENTUM NIT, CHAMOMILLA, CYCLAMEN, GELSEMIUM, IGNATIA, MAG MUR, MOSCHUS, NUX VOMICABestmade Natural Products2e8259e9-087f-8e19-e063-6294a90ab0842025-02-19WarningsExact identifier
unii: G0R4UBI2ZZ
Bestmade Natural Products BM142ACID PHOS, ARNICA MONT, CICHORIUM INTY, ECHINACEA ANG, GINSENG, PAEONIA OFF, SARSAPARILLA, SULPHUR, TRITICUM REP, URTICA URENSBestmade Natural Products2e682051-2d61-1578-e063-6394a90a5e992025-02-18WarningsExact identifier
unii: 70FD1KFU70
Bestmade Natural Products BM150ARALIA RAC, ARSENIC ALB, CACTUS GR, CUPRUM ACET, DROSERA, GLYCYRRHIZA GLAB, JUSTICIA ADHATODA, LOBELIA INFBestmade Natural Products2e6a1412-a76a-6716-e063-6294a90a84a92025-02-18WarningsExact identifier
unii: 2788Z9758H
Bestmade Natural Products BM152ACONITE, ANTI TART, BELLADONNA, CYCLAMEN, DULCAMARA, SULPHURBestmade Natural Products2e6aa8e8-22fa-687f-e063-6394a90a38022025-02-18WarningsExact identifier
unii: 70FD1KFU70
Bestmade Natural Products BM154ANTIMONIUM CRUD, ASAFOETIDA, CARBO VEG, CHELIDONIUM MAJUS, HYDRASTIS CAN, NUX MOSCHATA, PTELEA TRIBestmade Natural Products2e6b433b-f1b0-220a-e063-6294a90a5e612025-02-18WarningsExact identifier
unii: ZW3Z11D0JV
Bestmade Natural Products BM156MAG PHOS, ERIGERON, NUX MOS, IGNATIA, ALSTONIA, CHINA OFF, HYDRASTISBestmade Natural Products2e6be9ef-ad61-8f01-e063-6294a90a97752025-02-18WarningsExact identifier
unii: ZW3Z11D0JV
Bestmade Natural Products BM158CARDUUS MAR, CHELIDONIUM, MYRICA CER, HYDRASTIS, LEPTANDRA, PODOPHYLLUM, SECALE COR, TEREBINTHINABestmade Natural Products2e6c4198-e188-2ad0-e063-6394a90ad0562025-02-18WarningsExact identifier
unii: ZW3Z11D0JV
Bestmade Natural Products BM159ALETRIS FARINOSA, ASHOKA JANO, FLUORIC ACID, FUMARIC ACID, HYDRASTIS, HYDROCOTYLE ASIATICA, KALI BICH, KREASOTEBestmade Natural Products2e6c7481-b1cb-e3a6-e063-6294a90af0872025-02-18WarningsExact identifier
unii: ZW3Z11D0JV
Bestmade Natural Products BM160AMYL NIT, FRAXINUS AM, GRAPHITES, MAG PHOS, MAG SULPH, PULSATILLA, SABINA, SULPHURBestmade Natural Products2e6cbe2b-9aad-f73e-e063-6294a90a5a532025-02-18WarningsExact identifier
unii: 70FD1KFU70
Bestmade Natural Products BM164ACID PHOS, ARUM TRYPH, BALSAMUM PERU, CAUSTICUM, EQUISETUM, GLYCERINUM, HELONIAS DIOBestmade Natural Products2e6e49aa-278e-5499-e063-6394a90a999c2025-02-18WarningsExact identifier
unii: PDC6A3C0OX
Bestmade Natural Products BM141AGARICUS MUS, HYDROCOTYLE, KALI CARB, SECALE CORN, SULPHUR, SYMPHYTUMBestmade Natural Products2e5abb73-ca66-ec0d-e063-6394a90a43cc2025-02-17WarningsExact identifier
unii: 70FD1KFU70
Advanced Eye Relief Eye WashWATER SOLUTIONBausch & Lomb Incorporated9caccce1-4530-441d-bf76-244edeb9dedc2025-02-17WarningsExact identifier
unii: 059QF0KO0R
SODIUM PHENYLACETATE and SODIUM BENZOATESODIUM PHENYLACETATE AND SODIUM BENZOATEOmnivium Pharmaceuticals LLC9067c301-74f9-457a-9b0f-b7e9b06a35082025-02-15Warnings, Adverse reactionsExact identifier
unii: OJ245FE5EU

Reported adverse events (FAERS/openFDA)#

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