Cold Relief Zero Sugar Grape

Product NDC
53499-6794
11-digit product format
534996794
Labeler code
53499
Product ID
53499-6794_e92bbfee-40fb-4b9a-aacb-2444103d6ba1
Type
HUMAN OTC DRUG
Nonproprietary name
Pelargonium sidoides
Dosage form
SYRUP
Route
ORAL
Labeler
Schwabe North America, Inc
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2024-03-06
Substance
PELARGONIUM SIDOIDES ROOT
Active strength
1 [hp_X]/120mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cold Relief Zero Sugar Grape
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PELARGONIUM SIDOIDES ROOT1 [hp_X]/120mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiH6J53HEX8E

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53499-6794-5Cold Relief Zero Sugar Grape1 in 1 CARTONSYRUP13
53499-6794-5Cold Relief Zero Sugar Grape120 mL in 1 BOTTLE, PLASTICSYRUP1203

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53499-6794-5ML - Milliliter53499-67941e9c2139-6370-4d30-bb1a-d2954e302c2012025-10-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53499-6794COLD RELIEF ZERO SUGAR GRAPE (PELARGONIUM SIDOIDES) SYRUP [SCHWABE NORTH AMERICA, INC]2Current NDC, 2 package rows20250321_9160182c-a1c1-49db-8a3d-01a30f7cbd78.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
53499-6794-5534996794051 BOTTLE, PLASTIC in 1 CARTON (53499-6794-5) / 120 mL in 1 BOTTLE, PLASTIC2024-03-06NoNoHistorical