Home NDC 53499-6794 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 Ingredient Strength PELARGONIUM SIDOIDES ROOT 1 [hp_X]/120mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination H6J53HEX8E Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53499-6794-5 Cold Relief Zero Sugar Grape 1 in 1 CARTON SYRUP 1 3 53499-6794-5 Cold Relief Zero Sugar Grape 120 mL in 1 BOTTLE, PLASTIC SYRUP 120 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53499-6794 COLD RELIEF ZERO SUGAR GRAPE (PELARGONIUM SIDOIDES) SYRUP [SCHWABE NORTH AMERICA, INC] 2 Current NDC, 2 package rows 20250321_9160182c-a1c1-49db-8a3d-01a30f7cbd78.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 53499-6794-5 53499679405 1 BOTTLE, PLASTIC in 1 CARTON (53499-6794-5) / 120 mL in 1 BOTTLE, PLASTIC 2024-03-06 No No Current