Baby Nighttime Tiny Cold

Product NDC
54973-3180
Requested package NDC
54973-3180-3
11-digit product format
549733180
Labeler code
54973
Product ID
54973-3180_eea4461d-3cbb-a410-e053-2995a90a5558
Type
HUMAN OTC DRUG
Nonproprietary name
chamomile, eupatorium perfoliatum flowering top, euphrasia stricta, gelsemium sempervirens root, and potassium iodide
Dosage form
LIQUID
Route
ORAL
Labeler
Hyland's Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2014-07-01
Marketing end
0000-00-00
Substance
CHAMOMILE; EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM IODIDE
Active strength
6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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 packagepackage54973-318054973-3180-3DDiscontinued by firm2026-10-15

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…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHAMOMILEACTIVE INGREDIENTFGL3685T2XBABY NIGHTTIME TINY COLD (CHAMOMILE, EUPATORIUM PERFOLIATUM FLOWERING TOP, EUPHRASIA STRICTA, GELSEMIUM SEMPERVIRENS ROOT, AND POTASSIUM IODIDE) LIQUID [HYLAND'S]2
EUPATORIUM PERFOLIATUM FLOWERING TOPACTIVE INGREDIENT1W0775VX6EBABY NIGHTTIME TINY COLD (CHAMOMILE, EUPATORIUM PERFOLIATUM FLOWERING TOP, EUPHRASIA STRICTA, GELSEMIUM SEMPERVIRENS ROOT, AND POTASSIUM IODIDE) LIQUID [HYLAND'S]2
EUPHRASIA STRICTAACTIVE INGREDIENTC9642I91WLBABY NIGHTTIME TINY COLD (CHAMOMILE, EUPATORIUM PERFOLIATUM FLOWERING TOP, EUPHRASIA STRICTA, GELSEMIUM SEMPERVIRENS ROOT, AND POTASSIUM IODIDE) LIQUID [HYLAND'S]2
GELSEMIUM SEMPERVIRENS ROOTACTIVE INGREDIENT639KR60Q1QBABY NIGHTTIME TINY COLD (CHAMOMILE, EUPATORIUM PERFOLIATUM FLOWERING TOP, EUPHRASIA STRICTA, GELSEMIUM SEMPERVIRENS ROOT, AND POTASSIUM IODIDE) LIQUID [HYLAND'S]2
POTASSIUM IODIDEACTIVE INGREDIENT1C4QK22F9JBABY NIGHTTIME TINY COLD (CHAMOMILE, EUPATORIUM PERFOLIATUM FLOWERING TOP, EUPHRASIA STRICTA, GELSEMIUM SEMPERVIRENS ROOT, AND POTASSIUM IODIDE) LIQUID [HYLAND'S]2
CHAMOMILEACTIVE MOIETYFGL3685T2XBABY NIGHTTIME TINY COLD (CHAMOMILE, EUPATORIUM PERFOLIATUM FLOWERING TOP, EUPHRASIA STRICTA, GELSEMIUM SEMPERVIRENS ROOT, AND POTASSIUM IODIDE) LIQUID [HYLAND'S]2
EUPATORIUM PERFOLIATUM FLOWERING TOPACTIVE MOIETY1W0775VX6EBABY NIGHTTIME TINY COLD (CHAMOMILE, EUPATORIUM PERFOLIATUM FLOWERING TOP, EUPHRASIA STRICTA, GELSEMIUM SEMPERVIRENS ROOT, AND POTASSIUM IODIDE) LIQUID [HYLAND'S]2
EUPHRASIA STRICTAACTIVE MOIETYC9642I91WLBABY NIGHTTIME TINY COLD (CHAMOMILE, EUPATORIUM PERFOLIATUM FLOWERING TOP, EUPHRASIA STRICTA, GELSEMIUM SEMPERVIRENS ROOT, AND POTASSIUM IODIDE) LIQUID [HYLAND'S]2
GELSEMIUM SEMPERVIRENS ROOTACTIVE MOIETY639KR60Q1QBABY NIGHTTIME TINY COLD (CHAMOMILE, EUPATORIUM PERFOLIATUM FLOWERING TOP, EUPHRASIA STRICTA, GELSEMIUM SEMPERVIRENS ROOT, AND POTASSIUM IODIDE) LIQUID [HYLAND'S]2
IODIDE IONACTIVE MOIETY09G4I6V86QBABY NIGHTTIME TINY COLD (CHAMOMILE, EUPATORIUM PERFOLIATUM FLOWERING TOP, EUPHRASIA STRICTA, GELSEMIUM SEMPERVIRENS ROOT, AND POTASSIUM IODIDE) LIQUID [HYLAND'S]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPBABY NIGHTTIME TINY COLD (CHAMOMILE, EUPATORIUM PERFOLIATUM FLOWERING TOP, EUPHRASIA STRICTA, GELSEMIUM SEMPERVIRENS ROOT, AND POTASSIUM IODIDE) LIQUID [HYLAND'S]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBABY NIGHTTIME TINY COLD (CHAMOMILE, EUPATORIUM PERFOLIATUM FLOWERING TOP, EUPHRASIA STRICTA, GELSEMIUM SEMPERVIRENS ROOT, AND POTASSIUM IODIDE) LIQUID [HYLAND'S]2
GLYCYRRHIZA GLABRAINACTIVE INGREDIENT2788Z9758HBABY NIGHTTIME TINY COLD (CHAMOMILE, EUPATORIUM PERFOLIATUM FLOWERING TOP, EUPHRASIA STRICTA, GELSEMIUM SEMPERVIRENS ROOT, AND POTASSIUM IODIDE) LIQUID [HYLAND'S]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUBABY NIGHTTIME TINY COLD (CHAMOMILE, EUPATORIUM PERFOLIATUM FLOWERING TOP, EUPHRASIA STRICTA, GELSEMIUM SEMPERVIRENS ROOT, AND POTASSIUM IODIDE) LIQUID [HYLAND'S]2
WATERINACTIVE INGREDIENT059QF0KO0RBABY NIGHTTIME TINY COLD (CHAMOMILE, EUPATORIUM PERFOLIATUM FLOWERING TOP, EUPHRASIA STRICTA, GELSEMIUM SEMPERVIRENS ROOT, AND POTASSIUM IODIDE) LIQUID [HYLAND'S]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54973-3180-35497331800319.8 mL in 1 BOTTLE, PLASTIC (54973-3180-3) 19.8 ml2014-07-010000-00-00YesNoCurrent