Cough Relief

Product NDC
53499-6864
11-digit product format
534996864
Labeler code
53499
Product ID
53499-6864_a7c5f6a5-ce84-467a-aca0-866d1373a9a9
Type
HUMAN OTC DRUG
Nonproprietary name
Cough Relief
Dosage form
SYRUP
Route
ORAL
Labeler
Schwabe North America, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2024-01-19
Substance
ACONITUM NAPELLUS; BRYONIA ALBA ROOT; CALCIUM SULFIDE; PELARGONIUM SIDOIDES ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED; TIN
Active strength
3; 3; 6; 1; 3; 6 [hp_X]/120mL; [hp_X]/120mL; [hp_C]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_C]/120mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cough Relief
Brand name suffix
ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM SULFIDE, SPONGIA OFFICINALIS SKELETON, ROASTED , TIN, PELARGONIUM SIDOIDES ROOT
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACONITUM NAPELLUS3 [hp_X]/120mL
BRYONIA ALBA ROOT3 [hp_X]/120mL
CALCIUM SULFIDE6 [hp_C]/120mL
PELARGONIUM SIDOIDES ROOT1 [hp_X]/120mL
SPONGIA OFFICINALIS SKELETON, ROASTED3 [hp_X]/120mL
TIN6 [hp_C]/120mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU0NQ8555JD, T7J046YI2B, 1MBW07J51Q, H6J53HEX8E, 1PIP394IID, 387GMG9FH5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53499-6864-4Cough ReliefACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM SULFIDE, SPONGIA OFFICINALIS SKELETON, ROASTED , TIN, PELARGONIUM SIDOIDES ROOT120 mL in 1 BOTTLESYRUP1204
53499-6864-4Cough ReliefACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM SULFIDE, SPONGIA OFFICINALIS SKELETON, ROASTED , TIN, PELARGONIUM SIDOIDES ROOT1 in 1 BOXSYRUP14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53499-6864-4ML - Milliliter53499-6864cddcfb57-1980-44a6-b35e-a32671daab4412025-10-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53499-6864COUGH RELIEF ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM SULFIDE, SPONGIA OFFICINALIS SKELETON, ROASTED , TIN, PELARGONIUM SIDOIDES ROOT (COUGH RELIEF) SYRUP [SCHWABE NORTH AMERICA, INC.]2Current NDC, 2 package rows20250321_a95610e3-774b-4745-a2a4-fc3ba51ab4c5.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53499-6864-4534996864041 BOTTLE in 1 BOX (53499-6864-4) / 120 mL in 1 BOTTLE1 bottle2024-01-19NoNoCurrent