COUGH BABY

Product NDC
54973-3154
11-digit product format
549733154
Labeler code
54973
Product ID
54973-3154_4650bbda-1647-da3a-e063-6294a90a67fa
Type
HUMAN OTC DRUG
Nonproprietary name
ipecac, bryonia alba root, spongia officinalis skeleton, roasted, phosphorus, causticum, drosera rotundifolia, and rumex crispus root
Dosage form
SYRUP
Route
ORAL
Labeler
Hyland's Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2012-10-17
Substance
BRYONIA ALBA ROOT; CAUSTICUM; DROSERA ROTUNDIFOLIA; IPECAC; PHOSPHORUS; RUMEX CRISPUS ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED
Active strength
6; 6; 6; 6; 12; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
COUGH BABY
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BRYONIA ALBA ROOT6 [hp_X]/mL
CAUSTICUM6 [hp_X]/mL
DROSERA ROTUNDIFOLIA6 [hp_X]/mL
IPECAC6 [hp_X]/mL
PHOSPHORUS12 [hp_X]/mL
RUMEX CRISPUS ROOT6 [hp_X]/mL
SPONGIA OFFICINALIS SKELETON, ROASTED6 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiT7J046YI2B, DD5FO1WKFU, QR44N9XPJQ, 62I3C8233L, 27YLU75U4W, 9N1RM2S62C, 1PIP394IID

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54973-3154-1COUGH BABY19.81 mL in 1 BOTTLE, PLASTICSYRUP19.8111
54973-3154-2COUGH BABY118 mL in 1 BOTTLESYRUP11811

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BRYONIA ALBA ROOTACTIVE INGREDIENTT7J046YI2BCOUGH BABY (IPECAC, BRYONIA ALBA ROOT, SPONGIA OFFICINALIS SKELETON, ROASTED, PHOSPHORUS, CAUSTICUM, DROSERA ROTUNDIFOLIA, AND RUMEX CRISPUS ROOT) SYRUP [HYLAND'S]2
CAUSTICUMACTIVE INGREDIENTDD5FO1WKFUCOUGH BABY (IPECAC, BRYONIA ALBA ROOT, SPONGIA OFFICINALIS SKELETON, ROASTED, PHOSPHORUS, CAUSTICUM, DROSERA ROTUNDIFOLIA, AND RUMEX CRISPUS ROOT) SYRUP [HYLAND'S]2
DROSERA ROTUNDIFOLIAACTIVE INGREDIENTQR44N9XPJQCOUGH BABY (IPECAC, BRYONIA ALBA ROOT, SPONGIA OFFICINALIS SKELETON, ROASTED, PHOSPHORUS, CAUSTICUM, DROSERA ROTUNDIFOLIA, AND RUMEX CRISPUS ROOT) SYRUP [HYLAND'S]2
IPECACACTIVE INGREDIENT62I3C8233LCOUGH BABY (IPECAC, BRYONIA ALBA ROOT, SPONGIA OFFICINALIS SKELETON, ROASTED, PHOSPHORUS, CAUSTICUM, DROSERA ROTUNDIFOLIA, AND RUMEX CRISPUS ROOT) SYRUP [HYLAND'S]2
PHOSPHORUSACTIVE INGREDIENT27YLU75U4WCOUGH BABY (IPECAC, BRYONIA ALBA ROOT, SPONGIA OFFICINALIS SKELETON, ROASTED, PHOSPHORUS, CAUSTICUM, DROSERA ROTUNDIFOLIA, AND RUMEX CRISPUS ROOT) SYRUP [HYLAND'S]2
RUMEX CRISPUS ROOTACTIVE INGREDIENT9N1RM2S62CCOUGH BABY (IPECAC, BRYONIA ALBA ROOT, SPONGIA OFFICINALIS SKELETON, ROASTED, PHOSPHORUS, CAUSTICUM, DROSERA ROTUNDIFOLIA, AND RUMEX CRISPUS ROOT) SYRUP [HYLAND'S]2
SPONGIA OFFICINALIS SKELETON, ROASTEDACTIVE INGREDIENT1PIP394IIDCOUGH BABY (IPECAC, BRYONIA ALBA ROOT, SPONGIA OFFICINALIS SKELETON, ROASTED, PHOSPHORUS, CAUSTICUM, DROSERA ROTUNDIFOLIA, AND RUMEX CRISPUS ROOT) SYRUP [HYLAND'S]2
BRYONIA ALBA ROOTACTIVE MOIETYT7J046YI2BCOUGH BABY (IPECAC, BRYONIA ALBA ROOT, SPONGIA OFFICINALIS SKELETON, ROASTED, PHOSPHORUS, CAUSTICUM, DROSERA ROTUNDIFOLIA, AND RUMEX CRISPUS ROOT) SYRUP [HYLAND'S]2
CAUSTICUMACTIVE MOIETYDD5FO1WKFUCOUGH BABY (IPECAC, BRYONIA ALBA ROOT, SPONGIA OFFICINALIS SKELETON, ROASTED, PHOSPHORUS, CAUSTICUM, DROSERA ROTUNDIFOLIA, AND RUMEX CRISPUS ROOT) SYRUP [HYLAND'S]2
DROSERA ROTUNDIFOLIAACTIVE MOIETYQR44N9XPJQCOUGH BABY (IPECAC, BRYONIA ALBA ROOT, SPONGIA OFFICINALIS SKELETON, ROASTED, PHOSPHORUS, CAUSTICUM, DROSERA ROTUNDIFOLIA, AND RUMEX CRISPUS ROOT) SYRUP [HYLAND'S]2
IPECACACTIVE MOIETY62I3C8233LCOUGH BABY (IPECAC, BRYONIA ALBA ROOT, SPONGIA OFFICINALIS SKELETON, ROASTED, PHOSPHORUS, CAUSTICUM, DROSERA ROTUNDIFOLIA, AND RUMEX CRISPUS ROOT) SYRUP [HYLAND'S]2
PHOSPHORUSACTIVE MOIETY27YLU75U4WCOUGH BABY (IPECAC, BRYONIA ALBA ROOT, SPONGIA OFFICINALIS SKELETON, ROASTED, PHOSPHORUS, CAUSTICUM, DROSERA ROTUNDIFOLIA, AND RUMEX CRISPUS ROOT) SYRUP [HYLAND'S]2
RUMEX CRISPUS ROOTACTIVE MOIETY9N1RM2S62CCOUGH BABY (IPECAC, BRYONIA ALBA ROOT, SPONGIA OFFICINALIS SKELETON, ROASTED, PHOSPHORUS, CAUSTICUM, DROSERA ROTUNDIFOLIA, AND RUMEX CRISPUS ROOT) SYRUP [HYLAND'S]2
SPONGIA OFFICINALIS SKELETON, ROASTEDACTIVE MOIETY1PIP394IIDCOUGH BABY (IPECAC, BRYONIA ALBA ROOT, SPONGIA OFFICINALIS SKELETON, ROASTED, PHOSPHORUS, CAUSTICUM, DROSERA ROTUNDIFOLIA, AND RUMEX CRISPUS ROOT) SYRUP [HYLAND'S]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPCOUGH BABY (IPECAC, BRYONIA ALBA ROOT, SPONGIA OFFICINALIS SKELETON, ROASTED, PHOSPHORUS, CAUSTICUM, DROSERA ROTUNDIFOLIA, AND RUMEX CRISPUS ROOT) SYRUP [HYLAND'S]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCOUGH BABY (IPECAC, BRYONIA ALBA ROOT, SPONGIA OFFICINALIS SKELETON, ROASTED, PHOSPHORUS, CAUSTICUM, DROSERA ROTUNDIFOLIA, AND RUMEX CRISPUS ROOT) SYRUP [HYLAND'S]2
LICORICEINACTIVE INGREDIENT61ZBX54883COUGH BABY (IPECAC, BRYONIA ALBA ROOT, SPONGIA OFFICINALIS SKELETON, ROASTED, PHOSPHORUS, CAUSTICUM, DROSERA ROTUNDIFOLIA, AND RUMEX CRISPUS ROOT) SYRUP [HYLAND'S]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCOUGH BABY (IPECAC, BRYONIA ALBA ROOT, SPONGIA OFFICINALIS SKELETON, ROASTED, PHOSPHORUS, CAUSTICUM, DROSERA ROTUNDIFOLIA, AND RUMEX CRISPUS ROOT) SYRUP [HYLAND'S]2
WATERINACTIVE INGREDIENT059QF0KO0RCOUGH BABY (IPECAC, BRYONIA ALBA ROOT, SPONGIA OFFICINALIS SKELETON, ROASTED, PHOSPHORUS, CAUSTICUM, DROSERA ROTUNDIFOLIA, AND RUMEX CRISPUS ROOT) SYRUP [HYLAND'S]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-3154COUGH BABY (IPECAC, BRYONIA ALBA ROOT, SPONGIA OFFICINALIS SKELETON, ROASTED, PHOSPHORUS, CAUSTICUM, DROSERA ROTUNDIFOLIA, AND RUMEX CRISPUS ROOT) SYRUP [HYLAND'S INC.]10Current NDC, Legacy NDC, 2 package rows20221213_2daac16d-69d0-48bf-806f-f22c0a6973ad.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54973-3154-15497331540119.81 mL in 1 BOTTLE, PLASTIC (54973-3154-1) 19.81 ml2012-10-170000-00-00NoNoCurrent
54973-3154-254973315402118 mL in 1 BOTTLE (54973-3154-2) 118 ml2012-10-170000-00-00NoNoCurrent