Tiny Cold

Product NDC
54973-3158
Requested package NDC
54973-3158-2
11-digit product format
549733158
Labeler code
54973
Product ID
54973-3158_27768618-c3fa-755c-e063-6394a90a82b6
Type
HUMAN OTC DRUG
Nonproprietary name
eupatorium perfoliatum flowering top, euphrasia stricta, gelsemium sempervirens root, and potassium iodide
Dosage form
TABLET, SOLUBLE
Route
ORAL
Labeler
Hyland's Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2011-12-28
Substance
EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM IODIDE
Active strength
6; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
NDC exclude flag
No
Listing certified through
2026-12-31
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 packagepackage54973-315854973-3158-2DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Additional Listing Data#

Finished product
Yes
Brand name base
Tiny Cold
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM IODIDE6 [hp_X]/1
EUPATORIUM PERFOLIATUM FLOWERING TOP6 [hp_X]/1
EUPHRASIA STRICTA6 [hp_X]/1
GELSEMIUM SEMPERVIRENS ROOT6 [hp_X]/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1C4QK22F9JInternal UNII lookup
1W0775VX6EInternal UNII lookup
C9642I91WLInternal UNII lookup
639KR60Q1QInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7576bd5e-502e-4edf-99da-59cb1e97043fAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54973-3158-1Tiny Cold1 in 1 CARTONTABLET, SOLUBLE113
54973-3158-1Tiny Cold125 in 1 BOTTLE, PLASTICTABLET, SOLUBLE12513
54973-3158-2Tiny Cold1 in 1 CARTONTABLET, SOLUBLE113
54973-3158-2Tiny Cold135 in 1 BOTTLE, PLASTICTABLET, SOLUBLE13513
54973-3158-4Tiny Cold6 in 1 PACKETTABLET, SOLUBLE613
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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EUPATORIUM PERFOLIATUM FLOWERING TOPACTIVE INGREDIENT1W0775VX6ETINY COLD (EUPATORIUM PERFOLIATUM FLOWERING TOP, EUPHRASIA STRICTA, GELSEMIUM SEMPERVIRENS ROOT, AND POTASSIUM IODIDE) TABLET, SOLUBLE [HYLAND'S]2
EUPHRASIA STRICTAACTIVE INGREDIENTC9642I91WLTINY COLD (EUPATORIUM PERFOLIATUM FLOWERING TOP, EUPHRASIA STRICTA, GELSEMIUM SEMPERVIRENS ROOT, AND POTASSIUM IODIDE) TABLET, SOLUBLE [HYLAND'S]2
GELSEMIUM SEMPERVIRENS ROOTACTIVE INGREDIENT639KR60Q1QTINY COLD (EUPATORIUM PERFOLIATUM FLOWERING TOP, EUPHRASIA STRICTA, GELSEMIUM SEMPERVIRENS ROOT, AND POTASSIUM IODIDE) TABLET, SOLUBLE [HYLAND'S]2
POTASSIUM IODIDEACTIVE INGREDIENT1C4QK22F9JTINY COLD (EUPATORIUM PERFOLIATUM FLOWERING TOP, EUPHRASIA STRICTA, GELSEMIUM SEMPERVIRENS ROOT, AND POTASSIUM IODIDE) TABLET, SOLUBLE [HYLAND'S]2
EUPATORIUM PERFOLIATUM FLOWERING TOPACTIVE MOIETY1W0775VX6ETINY COLD (EUPATORIUM PERFOLIATUM FLOWERING TOP, EUPHRASIA STRICTA, GELSEMIUM SEMPERVIRENS ROOT, AND POTASSIUM IODIDE) TABLET, SOLUBLE [HYLAND'S]2
EUPHRASIA STRICTAACTIVE MOIETYC9642I91WLTINY COLD (EUPATORIUM PERFOLIATUM FLOWERING TOP, EUPHRASIA STRICTA, GELSEMIUM SEMPERVIRENS ROOT, AND POTASSIUM IODIDE) TABLET, SOLUBLE [HYLAND'S]2
GELSEMIUM SEMPERVIRENS ROOTACTIVE MOIETY639KR60Q1QTINY COLD (EUPATORIUM PERFOLIATUM FLOWERING TOP, EUPHRASIA STRICTA, GELSEMIUM SEMPERVIRENS ROOT, AND POTASSIUM IODIDE) TABLET, SOLUBLE [HYLAND'S]2
IODIDE IONACTIVE MOIETY09G4I6V86QTINY COLD (EUPATORIUM PERFOLIATUM FLOWERING TOP, EUPHRASIA STRICTA, GELSEMIUM SEMPERVIRENS ROOT, AND POTASSIUM IODIDE) TABLET, SOLUBLE [HYLAND'S]2
ACACIAINACTIVE INGREDIENT5C5403N26OTINY COLD (EUPATORIUM PERFOLIATUM FLOWERING TOP, EUPHRASIA STRICTA, GELSEMIUM SEMPERVIRENS ROOT, AND POTASSIUM IODIDE) TABLET, SOLUBLE [HYLAND'S]2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GTINY COLD (EUPATORIUM PERFOLIATUM FLOWERING TOP, EUPHRASIA STRICTA, GELSEMIUM SEMPERVIRENS ROOT, AND POTASSIUM IODIDE) TABLET, SOLUBLE [HYLAND'S]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-3158TINY COLD (EUPATORIUM PERFOLIATUM FLOWERING TOP, EUPHRASIA STRICTA, GELSEMIUM SEMPERVIRENS ROOT, AND POTASSIUM IODIDE) TABLET, SOLUBLE [HYLAND'S INC.]13Current NDC, Legacy NDC, 5 package rows20241123_7576bd5e-502e-4edf-99da-59cb1e97043f.zip
54973-3158BABY 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 NDC20250406_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
Tiny ColdEUPATORIUM PERFOLIATUM FLOWERING TOP, EUPHRASIA STRICTA, GELSEMIUM SEMPERVIRENS ROOT, AND POTASSIUM IODIDEHyland's Inc.7576bd5e-502e-4edf-99da-59cb1e97043f2024-11-21WarningsExact identifier
ndc (package): 54973-3158-2
ndc (product): 54973-3158
ndc11 (package): 54973315802

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
54973-3158-2549733158021 BOTTLE, PLASTIC in 1 CARTON (54973-3158-2) > 135 TABLET, SOLUBLE in 1 BOTTLE, PLASTIC2011-12-280000-00-00NoNoCurrent