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 34 of 168 · 3,349 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TMJ Drops 2154TMJ DROPSProfessional Complementary Health Formulasa937e0e7-899d-48db-af58-9e0c11d5a24c2026-01-08WarningsExact identifier
unii: 1MBW07J51Q
Cataract Drops 2085CATARACT DROPSProfessional Complementary Health Formulas6040a096-ccdb-4e1e-a242-be29c3127f272026-01-08WarningsExact identifier
unii: 27YLU75U4W
unii: 451W47IQ8X
Insomnia Drops 2035INSOMNIA DROPSProfessional Complementary Health Formulas49dcc73f-2a20-4938-8671-0fa9dd39d5b82026-01-08WarningsExact identifier
unii: 3SW678MX72
Secale Combination 9244SECALE COMBINATIONProfessional Complementary Health Formulas6f68121f-48ac-478c-ad02-434db259920a2026-01-08WarningsExact identifier
unii: 27YLU75U4W
Toxagent Detox 6035TOXAGENT DETOXProfessional Complementary Health Formulase1476ce1-32ff-4c25-a330-dc78908f55912026-01-08WarningsExact identifier
unii: 492225Q21H
unii: 70FD1KFU70
Ulcer Drops 2094ULCER DROPSProfessional Complementary Health Formulas92cfc484-e3bc-4f04-a06a-3299c8522e322026-01-08WarningsExact identifier
unii: 2788Z9758H
unii: ZW3Z11D0JV
Learning Disability Drops 2040LEARNING DISABILITY DROPSProfessional Complementary Health Formulasc87531e6-4647-4127-a6ce-20ac296063cb2026-01-08WarningsExact identifier
unii: 27YLU75U4W
Lycopodium Combination 9231LYCOPODIUM COMBINATIONProfessional Complementary Health Formulas0403922e-dce1-4925-8877-d6b765f7fc182026-01-08WarningsExact identifier
unii: 27YLU75U4W
Lymph Stim Liquescence 3016LYMPH STIM LIQUESCENCEProfessional Complementary Health Formulasd91939ea-e3dc-49b1-949a-6618a4c4ae0d2026-01-08WarningsExact identifier
unii: ZW3Z11D0JV
Digestive Stimulator Formula 2069DIGESTIVE STIMULATOR FORMULAProfessional Complementary Health Formulas1d3795d0-7d95-4b9c-b2fe-195460e645c82026-01-08WarningsExact identifier
unii: 2788Z9758H
Psorinum Miasm Drops 2054PSORINUM MIASM DROPSProfessional Complementary Health Formulasa34aadab-b634-461f-a0ff-58f42f6e08332026-01-08WarningsExact identifier
unii: 27YLU75U4W
unii: 451W47IQ8X
unii: 70FD1KFU70
unii: 1MBW07J51Q
Digestive Enzyme Liquescence 3007DIGESTIVE ENZYME LIQUESCENCEProfessional Complementary Health Formulas74ce6879-ca7f-4664-949b-94abca92bc672026-01-08WarningsExact identifier
unii: ZW3Z11D0JV
Opsin II 6015OPSIN IIProfessional Complementary Health Formulas848d620e-ddd5-4787-a4bd-844be76154322026-01-08WarningsExact identifier
unii: 451W47IQ8X
unii: 492225Q21H
Aralia Combination 9256ARALIA COMBINATIONProfessional Complementary Health Formulasc7248bb6-187d-4076-85dd-94753f7da3b52026-01-08WarningsExact identifier
unii: ZW3Z11D0JV
unii: 70FD1KFU70
RET Small Intestine 7010RET SMALL INTESTINEProfessional Complementary Health Formulas0be84681-1dd1-46bf-96ec-e7cde89ab31d2026-01-08WarningsExact identifier
unii: 27YLU75U4W
Tinnitus Drops 2072TINNITUS DROPSProfessional Complementary Health Formulas24649b5b-ed21-4a32-8501-196b9e1348bb2026-01-08WarningsExact identifier
unii: ZW3Z11D0JV
unii: 70FD1KFU70
Mycobacter/Mycoplasma Nosode 4009MYCOBACTER/MYCOPLASMA NOSODEProfessional Complementary Health Formulas157e22fa-0791-4e8b-9d3a-7b6e94882c662026-01-08WarningsExact identifier
unii: 70FD1KFU70
Blood Clenz Drops 2012BLOOD CLENZ DROPSProfessional Complementary Health Formulas80a273da-bce5-4e37-89da-f40db0491e622026-01-08WarningsExact identifier
unii: 1MBW07J51Q
Northwest Regional 1019NORTHWEST REGIONALProfessional Complementary Health Formulas4dccc9f6-4d9e-4eec-b031-1fccdddb3d032026-01-08WarningsExact identifier
unii: 451W47IQ8X
Organic Acid Combination 9305ORGANIC ACID COMBINATIONProfessional Complementary Health Formulasf2e752c9-2cf1-4511-bf07-5cf422af759c2026-01-08WarningsExact identifier
unii: 70FD1KFU70

Reported adverse events (FAERS/openFDA)#

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