FDA.reportPublic FDA data

NDC 54973-3400-01 - 4 Kids Cold and Cough Daytime

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
54973-3400
Requested NDC
54973-3400-01
Package NDCs from labels
54973-3400-1, 54973-3400-01
Manufacturer
Hyland's Inc. | LGM Pharma Solutions, LLC
Effective date
2025-12-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
4 Kids Cold and Cough Daytime - Hyland's Inc. | LGM Pharma Solutions, LLCHyland's Inc. | LGM Pharma Solutions, LLC2025-12-19HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54973-3400-14 Kids Cold and Cough Daytime1 in 1 CARTONLIQUID14
54973-3400-14 Kids Cold and Cough Daytime148 mL in 1 BOTTLE, PLASTICLIQUID1484

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-34004 KIDS COLD AND COUGH DAYTIME (ONION, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS, SULFUR, AND GOLDENSEAL) LIQUID [HYLAND'S INC.]3Current NDC, Legacy NDC, 2 package rows20221119_804e0e7a-20eb-128b-e053-2991aa0aa82c.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 7 of 157 · 3,132 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SalineNASALBEST CHOICE (VALU MERCHANDISERS COMPANY)71485e82-bf54-4b8b-8dd2-2a07615345202026-07-17WarningsExact identifier
unii: 451W47IQ8X
PridICHTHAMMOL, CALCIUM SULFIDE, CALENDULA OFFICINALIS FLOWERING TOP, ARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, SILICON DIOXIDE, SULFURHyland's Inc.49689eeb-7790-07f1-e063-6294a90a2df22026-07-16WarningsExact identifier
unii: 70FD1KFU70
unii: 1MBW07J51Q
Leg Cramps PMOYSTER SHELL CALCIUM CARBONATE, CRUDE, CAUSTICUM, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, COPPER, LYCOPODIUM CLAVATUM SPORE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDE, AND SULFURHyland's Inc.b0574a7e-88fa-417e-b6d5-60ced59eba472026-07-15WarningsExact identifier
unii: 70FD1KFU70
Sodium ChlorideSODIUM CHLORIDELABORATORIOS GRIFOLS SAeb811d79-fdb8-1f1a-c2ad-1cc4bfc7eadf2026-07-15Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium Sulfacetamide and SulfurSODIUM SULFACETAMIDE AND SULFURAcella Pharmaceuticals, LLCc3ff4716-6009-4e29-9da9-ea740726cc3c2026-07-14Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Sodium Sulfacetamide 9 Sulfur 4.5 WashSULFACETAMIDE SODIUM AND SULFURAcella Pharmaceuticals, LLCa761feea-86b6-44f0-8f9a-50d29ebb60e92026-07-14Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
SODIUM SULFACETAMIDE - SULFUR WASHSODIUM SULFACETAMIDE, SULFURACELLA PHARMACEUTICALSd9c5e993-e82a-436f-bd95-8984935c65512026-07-14Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Sodium Sulfacetamide 10 Sulfur 5 CleanserSULFACETAMIDE SODIUM AND SULFURAcella Pharmaceuticals, LLC1926eadd-d11f-44fa-971f-0041060f75892026-07-14Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
SODIUM SULFACETAMIDE, SULFURSODIUM SULFACETAMIDE AND SULFURAcella Pharmaceuticals, LLC99705c54-b7af-423d-8f20-881e8fea236f2026-07-13Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Magnilife Eczema CareSULFUR, GRAPHITE, DAPHNE MEZEREUM BARK, TOXICODENDRON PUBESCENS WHOLEThe Magni Group, Inc.8e3fc743-4c82-4a03-a963-2d5f93a1bc262026-07-13WarningsExact identifier
unii: 70FD1KFU70
Sodium Sulfacetamide 10 Sulfur 2 creamSULFACETAMIDE SODIUM AND SULFURAcella Pharmaceuticals, LLCa57b734d-5d6d-4cd7-8003-9174cc785e412026-07-13Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Sodium Sulfacetamide 10 Sulfur 2 CleanserSULFACETAMIDE SODIUM AND SULFURAcella Pharmaceuticals, LLC210774a9-aaab-4bd4-ac5a-481ed72e0c0c2026-07-13Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Sodium Sulfacetamide 9.8% and Sulfur 4.8% CleanserSULFACETAMIDE SODIUM, SULFURAcella Pharmaceuticals, LLCb21b36da-5475-4b01-8afd-1598f29c9b5d2026-07-13Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
WHWSWB 0.9% SALINESODIUM CHLORIDEYiwu Huanshu E-commerce Co., Ltd5082b773-79b2-2501-e063-6394a90a170f2026-07-11WarningsExact identifier
unii: 451W47IQ8X
Terramed Just Think Comfort GynoCare BV Guard Vaginal Symptoms ReliefOLIVE EXTRACT,HYDRASTIS,BORAX,CALENDULA OFFICINALISRida LLC5c42c8ae-3610-4fc9-b764-ccf22340d9ce2026-07-09WarningsExact identifier
unii: ZW3Z11D0JV
Freskaro Ear Drops for SwimmersFRESKARO EAR DROPS FOR SWIMMERSPharma Nobis, LLC4f724d85-cd38-41da-e063-6394a90a9fd72026-07-08WarningsExact identifier
unii: PDC6A3C0OX
SALINE NASALSODIUM CHLORIDEALAINA HEALTHCARE PRIVATE LIMITEDed30a7f9-7132-42da-9bed-63a9b1c80ab22026-07-07WarningsExact identifier
unii: 451W47IQ8X
Artificial TearsARTIFICIAL TEARSAvPAKf18bebf2-1936-658f-e053-2a95a90a50122026-07-07WarningsExact identifier
unii: PDC6A3C0OX
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: PDC6A3C0OX
unii: 059QF0KO0R
JOCK BLOCKSULFURKing-Tech Industry, Inc.6c368442-d7a5-4df8-9ed0-9e04c62b2be62026-07-02WarningsExact identifier
unii: 70FD1KFU70

Reported adverse events (FAERS/openFDA)#

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