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 105 of 163 · 3,251 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ChamomillaMATRICARIA RECUTITABoiron724d4680-7a53-11e6-b1ab-424c583030312024-07-23Exact identifier
unii: G0R4UBI2ZZ
ChamomillaMATRICARIA CHAMOMILLABoiron8519369a-b96f-4bf7-e053-2991aa0aee3a2024-07-23Exact identifier
unii: G0R4UBI2ZZ
Breath HPAMMONIUM MURIATICUM, ANTIMONIUM TARTARICUM, ARSENICUM ALBUM, BRYONIA (ALBA), CALCAREA CARBONICA, LOBELIA INFLATA, NATRUM SULPHURICUM, PHOSPHORUS, SPONGIA TOSTAEnergique, Inc.f487452a-e3de-4cd1-bda7-90b6b4daf9712024-07-23WarningsExact identifier
unii: 27YLU75U4W
ChamomillaMATRICARIA CHAMOMILLABoiron851978dd-d0dd-208c-e053-2a91aa0a30c52024-07-22Exact identifier
unii: G0R4UBI2ZZ
ChamomillaMATRICARIA CHAMOMILLABoiron8519e65a-803a-2986-e053-2a91aa0aadfd2024-07-22Exact identifier
unii: G0R4UBI2ZZ
ChamomillaMATRICARIA CHAMOMILLABoiron851950ec-62b1-30ad-e053-2991aa0a19bd2024-07-22Exact identifier
unii: G0R4UBI2ZZ
ChamomillaMATRICARIA CHAMOMILLABoiron851a1844-b599-62c5-e053-2a91aa0a81742024-07-22Exact identifier
unii: G0R4UBI2ZZ
Sodium chlorideSODIUM CHLORIDEFresenius Kabi USA, LLC83994d0c-8484-4505-abb5-8a384ed122882024-07-22Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
BladdertoneSARSAPARILLA, UVA-URSI, ARSENICUM ALBUM, CANTHARIS, PAREIRA BRAVA, PULSATILLA, SEPIA, TEREBINTHINA, POPULUS TREMULOIDESEnergique, Inc.125d7369-f384-4bc1-a1a3-40e8d6a9ea8c2024-07-22WarningsExact identifier
unii: I76KB35JEV
Animal AntigensARSENICUM ALBUM, NUX VOMICA, PHOSPHORUS, CANARY FEATHERS, CAT HAIR MIX, CHICKEN FEATHERS, COW HAIR, DOG HAIR MIX, GUINEA PIG HAIR, HAMSTER HAIR, HORSE DANDER, MUS MUSCULUS, PIG HAIR, RAT HAIR, DUCK FEATHERS, GOOSE FEATHERS, RABBIT FUREnergique, Inc.3dda6803-def4-464f-8271-eb36146e48732024-07-16WarningsExact identifier
unii: 27YLU75U4W
AdditivestatTRIFOLIUM PRATENSE, PETROLEUM, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, NITRICUM ACIDUMEnergique, Inc.8a9490c2-1fdb-43b4-aeae-6e783b333f032024-07-16WarningsExact identifier
unii: 27YLU75U4W
sodium chlorideSODIUM CHLORIDEBecton Dickinson and Company8df7dcf6-8714-6caf-e053-2995a90ab8cc2024-07-15Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Thompson Safety EyewashWATERThompson Safety1d0e96cf-245b-cfb7-e063-6294a90a4ced2024-07-12WarningsExact identifier
unii: 059QF0KO0R
RelaxatonePASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDAEnergique, Inc.98fd169f-84b7-415e-a7e8-bbb7d7f81ac42024-07-12WarningsExact identifier
unii: 3SW678MX72
Zenibell Snail IntensiveCreamGLYCERINMISOCOS97c19dca-237c-c968-e053-2a95a90aeae72024-07-05WarningsExact identifier
unii: PDC6A3C0OX
Zenibell Snail Intensive TonerGLYCERINMISOCOS97c1b556-824d-bef7-e053-2a95a90ae1f22024-07-05WarningsExact identifier
unii: PDC6A3C0OX
aewajin Derma HydrocellGLYCERINMISOCOS980fcaea-27ba-da49-e053-2995a90ad5062024-07-05WarningsExact identifier
unii: PDC6A3C0OX
aewajin Derma Hydrocell 24k Gold SerumGLYCERINMISOCOSa17b2c6e-9db8-bae4-e053-2a95a90adcf62024-07-05WarningsExact identifier
unii: PDC6A3C0OX
Bunnies Bum Soothing HemorrhoidalGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLFloCal Distributors LLC1c81582c-7ece-182f-e063-6294a90a8fbc2024-07-05WarningsExact identifier
unii: PDC6A3C0OX
Zenibell Snail IntensiveGLYCERINMISOCOS97747267-26f1-d06f-e053-2a95a90ab0872024-07-04WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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