Home NDC 54973-3154-1 COUGH BABY
Product NDC 54973-3154
Requested package NDC 54973-3154-1
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 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.
Additional Listing Data#
Finished product Yes
Brand name base COUGH BABY
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IPECAC 6 [hp_X]/mL BRYONIA ALBA ROOT 6 [hp_X]/mL SPONGIA OFFICINALIS SKELETON, ROASTED 6 [hp_X]/mL PHOSPHORUS 6 [hp_X]/mL CAUSTICUM 12 [hp_X]/mL DROSERA ROTUNDIFOLIA 6 [hp_X]/mL RUMEX CRISPUS ROOT 6 [hp_X]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 7 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 54973-3154-1 COUGH BABY 19.81 mL in 1 BOTTLE, PLASTIC SYRUP 19.81 11 54973-3154-2 COUGH BABY 118 mL in 1 BOTTLE SYRUP 118 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BRYONIA ALBA ROOT ACTIVE INGREDIENT T7J046YI2B COUGH BABY (IPECAC, BRYONIA ALBA ROOT, SPONGIA OFFICINALIS SKELETON, ROASTED, PHOSPHORUS, CAUSTICUM, DROSERA ROTUNDIFOLIA, AND RUMEX CRISPUS ROOT) SYRUP [HYLAND'S] 2 CAUSTICUM ACTIVE INGREDIENT DD5FO1WKFU COUGH BABY (IPECAC, BRYONIA ALBA ROOT, SPONGIA OFFICINALIS SKELETON, ROASTED, PHOSPHORUS, CAUSTICUM, DROSERA ROTUNDIFOLIA, AND RUMEX CRISPUS ROOT) SYRUP [HYLAND'S] 2 DROSERA ROTUNDIFOLIA ACTIVE INGREDIENT QR44N9XPJQ COUGH BABY (IPECAC, BRYONIA ALBA ROOT, SPONGIA OFFICINALIS SKELETON, ROASTED, PHOSPHORUS, CAUSTICUM, DROSERA ROTUNDIFOLIA, AND RUMEX CRISPUS ROOT) SYRUP [HYLAND'S] 2 IPECAC ACTIVE INGREDIENT 62I3C8233L COUGH BABY (IPECAC, BRYONIA ALBA ROOT, SPONGIA OFFICINALIS SKELETON, ROASTED, PHOSPHORUS, CAUSTICUM, DROSERA ROTUNDIFOLIA, AND RUMEX CRISPUS ROOT) SYRUP [HYLAND'S] 2 PHOSPHORUS ACTIVE INGREDIENT 27YLU75U4W COUGH BABY (IPECAC, BRYONIA ALBA ROOT, SPONGIA OFFICINALIS SKELETON, ROASTED, PHOSPHORUS, CAUSTICUM, DROSERA ROTUNDIFOLIA, AND RUMEX CRISPUS ROOT) SYRUP [HYLAND'S] 2 RUMEX CRISPUS ROOT ACTIVE INGREDIENT 9N1RM2S62C COUGH BABY (IPECAC, BRYONIA ALBA ROOT, SPONGIA OFFICINALIS SKELETON, ROASTED, PHOSPHORUS, CAUSTICUM, DROSERA ROTUNDIFOLIA, AND RUMEX CRISPUS ROOT) SYRUP [HYLAND'S] 2 SPONGIA OFFICINALIS SKELETON, ROASTED ACTIVE INGREDIENT 1PIP394IID COUGH BABY (IPECAC, BRYONIA ALBA ROOT, SPONGIA OFFICINALIS SKELETON, ROASTED, PHOSPHORUS, CAUSTICUM, DROSERA ROTUNDIFOLIA, AND RUMEX CRISPUS ROOT) SYRUP [HYLAND'S] 2 BRYONIA ALBA ROOT ACTIVE MOIETY T7J046YI2B COUGH BABY (IPECAC, BRYONIA ALBA ROOT, SPONGIA OFFICINALIS SKELETON, ROASTED, PHOSPHORUS, CAUSTICUM, DROSERA ROTUNDIFOLIA, AND RUMEX CRISPUS ROOT) SYRUP [HYLAND'S] 2 CAUSTICUM ACTIVE MOIETY DD5FO1WKFU COUGH BABY (IPECAC, BRYONIA ALBA ROOT, SPONGIA OFFICINALIS SKELETON, ROASTED, PHOSPHORUS, CAUSTICUM, DROSERA ROTUNDIFOLIA, AND RUMEX CRISPUS ROOT) SYRUP [HYLAND'S] 2 DROSERA ROTUNDIFOLIA ACTIVE MOIETY QR44N9XPJQ COUGH BABY (IPECAC, BRYONIA ALBA ROOT, SPONGIA OFFICINALIS SKELETON, ROASTED, PHOSPHORUS, CAUSTICUM, DROSERA ROTUNDIFOLIA, AND RUMEX CRISPUS ROOT) SYRUP [HYLAND'S] 2 IPECAC ACTIVE MOIETY 62I3C8233L COUGH BABY (IPECAC, BRYONIA ALBA ROOT, SPONGIA OFFICINALIS SKELETON, ROASTED, PHOSPHORUS, CAUSTICUM, DROSERA ROTUNDIFOLIA, AND RUMEX CRISPUS ROOT) SYRUP [HYLAND'S] 2 PHOSPHORUS ACTIVE MOIETY 27YLU75U4W COUGH BABY (IPECAC, BRYONIA ALBA ROOT, SPONGIA OFFICINALIS SKELETON, ROASTED, PHOSPHORUS, CAUSTICUM, DROSERA ROTUNDIFOLIA, AND RUMEX CRISPUS ROOT) SYRUP [HYLAND'S] 2 RUMEX CRISPUS ROOT ACTIVE MOIETY 9N1RM2S62C COUGH BABY (IPECAC, BRYONIA ALBA ROOT, SPONGIA OFFICINALIS SKELETON, ROASTED, PHOSPHORUS, CAUSTICUM, DROSERA ROTUNDIFOLIA, AND RUMEX CRISPUS ROOT) SYRUP [HYLAND'S] 2 SPONGIA OFFICINALIS SKELETON, ROASTED ACTIVE MOIETY 1PIP394IID COUGH BABY (IPECAC, BRYONIA ALBA ROOT, SPONGIA OFFICINALIS SKELETON, ROASTED, PHOSPHORUS, CAUSTICUM, DROSERA ROTUNDIFOLIA, AND RUMEX CRISPUS ROOT) SYRUP [HYLAND'S] 2 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP COUGH BABY (IPECAC, BRYONIA ALBA ROOT, SPONGIA OFFICINALIS SKELETON, ROASTED, PHOSPHORUS, CAUSTICUM, DROSERA ROTUNDIFOLIA, AND RUMEX CRISPUS ROOT) SYRUP [HYLAND'S] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX COUGH BABY (IPECAC, BRYONIA ALBA ROOT, SPONGIA OFFICINALIS SKELETON, ROASTED, PHOSPHORUS, CAUSTICUM, DROSERA ROTUNDIFOLIA, AND RUMEX CRISPUS ROOT) SYRUP [HYLAND'S] 2 LICORICE INACTIVE INGREDIENT 61ZBX54883 COUGH BABY (IPECAC, BRYONIA ALBA ROOT, SPONGIA OFFICINALIS SKELETON, ROASTED, PHOSPHORUS, CAUSTICUM, DROSERA ROTUNDIFOLIA, AND RUMEX CRISPUS ROOT) SYRUP [HYLAND'S] 2 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU COUGH BABY (IPECAC, BRYONIA ALBA ROOT, SPONGIA OFFICINALIS SKELETON, ROASTED, PHOSPHORUS, CAUSTICUM, DROSERA ROTUNDIFOLIA, AND RUMEX CRISPUS ROOT) SYRUP [HYLAND'S] 2 WATER INACTIVE INGREDIENT 059QF0KO0R COUGH 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 NDC Dashboard title SPL version Validation Dashboard ZIP 54973-3154 COUGH BABY (IPECAC, BRYONIA ALBA ROOT, SPONGIA OFFICINALIS SKELETON, ROASTED, PHOSPHORUS, CAUSTICUM, DROSERA ROTUNDIFOLIA, AND RUMEX CRISPUS ROOT) SYRUP [HYLAND'S INC.] 10 Current NDC, Legacy NDC, 2 package rows 20221213_2daac16d-69d0-48bf-806f-f22c0a6973ad.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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join COUGH BABY IPECAC, BRYONIA ALBA ROOT, SPONGIA OFFICINALIS SKELETON, ROASTED, PHOSPHORUS, CAUSTICUM, DROSERA ROTUNDIFOLIA, AND RUMEX CRISPUS ROOT Hyland's Inc. 2daac16d-69d0-48bf-806f-f22c0a6973ad 2025-12-19 Warnings Exact identifier ndc (package): 54973-3154-1 ndc (product): 54973-3154 ndc11 (package): 54973315401
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 54973-3154-1 54973315401 19.81 mL in 1 BOTTLE, PLASTIC (54973-3154-1) 19.81 ml 2012-10-17 0000-00-00 No No Current