FDA.reportPublic FDA data

Baby Tiny Cold Daytime and Nighttime

Product NDC
54973-3307
Requested package NDC
54973-3307-1
11-digit product format
549733307
Labeler code
54973
Product ID
54973-3307_597e51b4-e8c1-4593-e063-6294a90ace9b
Type
HUMAN OTC DRUG
Nonproprietary name
eupatorium perfoliatum flowering top, euphrasia stricta, gelsemium sempervirens root, potassium iodide, and matricaria recutita
Dosage form
KIT
Labeler
Hyland's Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2017-01-11
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage54973-330754973-3307-1DDiscontinued by firm2026-09-14

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Baby Tiny Cold Daytime and Nighttime
Listing expiration
2027-12-31

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
be7cff09-ecff-48bd-96d4-dc7d47db7656Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54973-3158-1Baby Tiny Cold Daytime and Nighttime125 in 1 BOTTLE, PLASTICTABLET, SOLUBLE1256 [hp_X]9
54973-3158-1Baby Tiny Cold Daytime and Nighttime1 in 1 CARTONTABLET, SOLUBLE6 [hp_X]9
54973-3252-1Baby Tiny Cold Daytime and Nighttime125 in 1 BOTTLE, PLASTICTABLET1256 [hp_X]9
54973-3252-1Baby Tiny Cold Daytime and Nighttime1 in 1 CARTONTABLET6 [hp_X]9
54973-3307-1Baby Tiny Cold Daytime and Nighttime1 in 1 CARTONKIT19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-3307BABY TINY COLD DAYTIME AND NIGHTTIME (EUPATORIUM PERFOLIATUM FLOWERING TOP, EUPHRASIA STRICTA, GELSEMIUM SEMPERVIRENS ROOT, POTASSIUM IODIDE, AND MATRICARIA RECUTITA) KIT [HYLAND'S INC.]9Current NDC, Legacy NDC, 5 package rows20250406_be7cff09-ecff-48bd-96d4-dc7d47db7656.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Baby Tiny Cold Daytime and NighttimeEUPATORIUM PERFOLIATUM FLOWERING TOP, EUPHRASIA STRICTA, GELSEMIUM SEMPERVIRENS ROOT, POTASSIUM IODIDE, AND MATRICARIA RECUTITAHyland's Inc.be7cff09-ecff-48bd-96d4-dc7d47db76562026-08-20WarningsExact identifier
ndc (package): 54973-3307-1
ndc (product): 54973-3307
ndc11 (package): 54973330701

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54973-3307-1549733307011 KIT in 1 CARTON (54973-3307-1) * 1 BOTTLE, PLASTIC in 1 CARTON (54973-3158-1) > 125 TABLET, SOLUBLE in 1 BOTTLE, PLASTIC * 1 BOTTLE, PLASTIC in 1 CARTON (54973-3252-1) > 125 TABLET in 1 BOTTLE, PLASTIC1 kit2017-01-110000-00-00NoNoCurrent