FDA.reportPublic FDA data

NDC 54973-4115-01 - Kids Stuffy Nose and Sinus

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
54973-4115
Requested NDC
54973-4115-01
Package NDCs from labels
54973-4115-1, 54973-4115-01
Manufacturer
Hyland's Consumer Health Inc.
Effective date
2022-08-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hyland's Naturals Kids Stuffy Nose & SinusHyland's Consumer Health Inc.2022-08-25HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54973-4115-1Kids Stuffy Nose and Sinus50 in 1 BOTTLE, PLASTICTABLET501
54973-4115-1Kids Stuffy Nose and Sinus1 in 1 CARTONTABLET11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-4115KIDS STUFFY NOSE AND SINUS (OYSTER SHELL CALCIUM CARBONATE, CRUDE, GOLDENSEAL, POTASSIUM DICHROMATE, PULSATILLA PRATENSIS WHOLE) TABLET [HYLAND'S CONSUMER HEALTH INC.]1Current NDC, Legacy NDC, 2 package rows20221201_e7157883-6b23-b61c-e053-2995a90afdc2.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 24 of 51 · 1,015 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
D-87PHYTOLACCA AMERICANA ROOT, SPONGIA OFFICINALIS SKELETON, ROASTED, FUCUS VESICULOSUS, THYROID, UNSPECIFIED, OYSTER SHELL CALCIUM CARBONATE, CRUDE, ARGININE, TYROSINE, AND NIACINDNA Labs, Inc.198c61a4-780e-4651-9a92-f629a86fead62025-01-13WarningsExact identifier
unii: 2E32821G6I
D-103ALUMINUM OXIDE, SILVER, GOLD, BERYLLIUM, CADMIUM, COPPER, CALCIUM SULFIDE, MERCURIC SULFATE, MOLYBDENUM, NICKEL, PLANTAGO MAJOR, PLATINUM, LEAD, ANEMONE PRATENSIS, SELENIUM, AND TINDNA Labs, Inc.f4efd03d-3f80-4694-9a02-b71b7e3e3f0d2025-01-13WarningsExact identifier
unii: 8E272251DI
D-45SILVER NITRATE, ARNICA MONTANA, ARUM MACULATUM ROOT, OYSTER SHELL CALCIUM CARBONATE, CRUDE, AND PHOSPHORUSDNA Labs, Inc.ef1b1a20-8215-4b63-8f4c-4158c3dec0622025-01-13WarningsExact identifier
unii: 2E32821G6I
D-47FERULA ASSA-FOETIDA RESIN, ARABICA COFFEE BEAN, NITROGLYCERIN, STRYCHNOS IGNATII SEED, LACHESIS MUTA VENOM, MOSCHUS MOSCHIFERUS MUSK SAC RESIN, AND ANEMONE PRATENSISDNA Labs, Inc.43bc349f-016d-41c8-88db-2e42abdf63ba2025-01-13WarningsExact identifier
unii: 8E272251DI
D-59FUCUS VESICULOSUS, SPONGIA OFFICINALIS SKELETON, ROASTED, GRAPHITE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, SODIUM SULFATE, AND CROTON OILDNA Labs, Inc.b153cf23-eb3b-4647-b7f4-44380d4983342025-01-13WarningsExact identifier
unii: 2E32821G6I
D-116OYSTER SHELL CALCIUM CARBONATE, CRUDE, TRIBASIC CALCIUM PHOSPHATE, CALCIUM FLUORIDE, WOOD CREOSOTE, AND THUJA OCCIDENTALIS LEAFY TWIGDNA Labs, Inc.d412056d-4c48-43ff-9d94-51165d0c8c872025-01-13WarningsExact identifier
unii: 2E32821G6I
D-94OYSTER SHELL CALCIUM CARBONATE, CRUDE, STRYCHNOS IGNATII SEED, SEPIA OFFICINALIS JUICE, BOS TAURUS ADRENAL GLAND, AND PRUNUS SPINOSA FLOWER BUDDNA Labs, Inc.b7ab3359-d26e-4b06-b410-f9c364a198752025-01-13WarningsExact identifier
unii: 2E32821G6I
D-112LACHESIS MUTA VENOM, SILICON DIOXIDE, SODIUM CHLORIDE, RANUNCULUS BULBOSUS, ACONITUM NAPELLUS, ACTIVATED CHARCOAL, NITROGLYCERIN, OYSTER SHELL CALCIUM CARBONATE, CRUDE, ANEMONE PRATENSIS, PLANTAGO MAJOR, ARSENIC TRIOXIDE, AND MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEDNA Labs, Inc.8d517ef2-3a1e-4393-9452-a4cd0f0a3bca2025-01-13WarningsExact identifier
unii: 2E32821G6I
unii: 8E272251DI
D-65ARSENIC TRIOXIDE, BERBERIS AQUIFOLIUM ROOT BARK, OYSTER SHELL CALCIUM CARBONATE, CRUDE, GRAPHITE, CENTELLA ASIATICA, AND SODIUM CHLORIDEDNA Labs, Inc.94d4b66a-f995-4516-bdcf-2152c2a624dd2025-01-13WarningsExact identifier
unii: 2E32821G6I
D-154ANAMIRTA COCCULUS, ARABICA COFFEE BEAN, ARSENICUM ALBUM, CALCAREA CARBONICA, GRAPHITE, NUX VOMICA, PHOSPHORUS, POTASSIUM CARBONATE, SULFURDNA Labsf53e05de-043c-4eb4-e053-2995a90ad9cf2025-01-13WarningsExact identifier
unii: 2E32821G6I
D-136SOMATROPIN, LONG-(ARG3)INSULIN-LIKE GROWTH FACTOR-I, ARSENIC TRIOXIDE, SAW PALMETTO, PLATINUM, OYSTER SHELL CALCIUM CARBONATE, CRUDE, BOS TAURUS ADRENAL CORTEX, BOS TAURUS PITUITARY GLAND, POSTERIOR, THYROID, UNSPECIFIED, AND BOS TAURUS HYPOTHALAMUSDNA Labs, Inc.d94be950-ce16-4c55-bbb3-af3f9c4d29d62025-01-13WarningsExact identifier
unii: 2E32821G6I
D-139ARSENICUM ALBUM, BELLADONNA, CALCAREA CARBONICA, CARBO VEGETABILIS, FERRUM PHOSPHORICUM, LYCOPODIUM, NATRUM PHOSPHORICUM, NUX VOMICA, PHOSPHORUS, PULSATILLA, HYDRASTISDNA Labs, Inc.e830774e-35c8-7309-e053-2995a90ae0432025-01-13WarningsExact identifier
unii: 2E32821G6I
unii: 8E272251DI
unii: ZW3Z11D0JV
D-153JUGLANS REGIA LEAF, LACHESIS, CALCAREA CARBONICA, LYCOPODIUM, PHOSPHORUS, MAGNESIUM PHOSPHATEDNA Labsf473b88f-527c-46be-e053-2995a90a73002025-01-13WarningsExact identifier
unii: 2E32821G6I
A-36BOS TAURUS ADRENAL GLAND, AGRIMONIA EUPATORIA, BELLIS PERENNIS, CAMPHOR (NATURAL), MATRICARIA CHAMOMILLA, EQUISETUM HYEMALE, FRAXINUS AMERICANA BARK, FORMICA RUFA, HISTAMINE DIHYDROCHLORIDE, IODINE, POTASSIUM DICHROMATE, CANIS LUPUS FAMILIARIS MILK, SODIUM CHLORIDE, ANEMONE PULSATILLA, SALIX NIGRA BARK, AND TOBACCO LEAFDNA Labs, Inc.161c4738-9ead-4687-9f5a-029d5a496e072025-01-09WarningsExact identifier
unii: T4423S18FM
AM-14SILVER, CALCIUM IODIDE, LYTTA VESICATORIA, COPPER, FERROUS IODIDE, GOLDENSEAL, IODINE, DAPHNE MEZEREUM BARK, PHOSPHORIC ACID, PHOSPHORUS, TOXICODENDRON PUBESCENS LEAF, AND RUMEX CRISPUS WHOLEDNA Labs, Inc.8bf2fde6-fd71-47f8-b5ec-c5e34857ab642025-01-09WarningsExact identifier
unii: ZW3Z11D0JV
N-3BERBERIS VULGARIS WHOLE, LYCOPODIUM CLAVATUM WHOLE, SMILAX ORNATA WHOLE, RUBIA TINCTORUM WHOLE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, AND PORK KIDNEYDNA Labs, Inc.36e3a243-af04-416a-ac85-0a9962e872a22025-01-09WarningsExact identifier
unii: 2E32821G6I
N-10SODIUM CHLORIDE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, SEPIA OFFICINALIS JUICE, IODINE, LYCOPODIUM CLAVATUM WHOLE, AND BOS TAURUS PITUITARY GLAND, POSTERIORDNA Labs, Inc.264d8093-70f3-43a5-bfc4-b719bb3e45e62025-01-09WarningsExact identifier
unii: 2E32821G6I
N-18OYSTER SHELL CALCIUM CARBONATE, CRUDE, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, NITRIC ACID, AND SUS SCROFA PINEAL GLANDDNA Labs, Inc.3565c5d5-dc68-4f3f-99ec-30f8952393e02025-01-09WarningsExact identifier
unii: 2E32821G6I
SnoreStop Extinguisher 120ATROPA BELLADONNA, EPHEDRA DISTACHYA FLOWERING TWIG, HISTAMINE DIHYDROCHLORIDE, GOLDENSEAL, POTASSIUM DICHROMATE, STRYCHNOS NUX-VOMICA SEED, TEUCRIUM MARUMGreen Pharmaceuticals Inceb534a2f-53ed-3924-e053-2a95a90a03512025-01-08WarningsExact identifier
unii: ZW3Z11D0JV
unii: T4423S18FM
SnoreStop Chewable Fast tabs 60ATROPA BELLADONNA,EPHEDRA DISTACHYA FLOWERING TWIG,HISTAMINE DIHYDROCHLORIDE,GOLDENSEAL,POTASSIUM DICHROMATE,STRYCHNOS NUX-VOMICA SEED,TEUCRIUM MARUMGreen Pharmaceuticals Inceb056b9a-e93b-37f7-e053-2995a90a1be12025-01-08WarningsExact identifier
unii: ZW3Z11D0JV
unii: T4423S18FM

Reported adverse events (FAERS/openFDA)#

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