FDA.reportPublic FDA data

Cold Relief Lemon

Product NDC
53499-6146
11-digit product format
534996146
Labeler code
53499
Product ID
53499-6146_d3410778-39cc-4789-9f7f-0d0aa5659eea
Type
HUMAN OTC DRUG
Nonproprietary name
Pelargonium sidoides
Dosage form
POWDER
Route
ORAL
Labeler
Schwabe North America, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2009-07-01
Substance
PELARGONIUM SIDOIDES ROOT
Active strength
1 [hp_X]/5g
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 Lemon
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PELARGONIUM SIDOIDES ROOT1 [hp_X]/5g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
H6J53HEX8EInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f5c9b1c4-dbc6-4fa3-bc41-4ee4bf417eb5Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53499-6146-0Cold Relief Lemon5 g in 1 PACKETPOWDER53
53499-6146-0Cold Relief Lemon10 in 1 CARTONPOWDER103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53499-6146-0EA - Each53499-6146e7dc1bc8-ad7b-43d3-8a59-a4ce5a4a69a812025-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53499-6146COLD RELIEF LEMON (PELARGONIUM SIDOIDES) POWDER [SCHWABE NORTH AMERICA, INC.]2Current NDC, 2 package rows20250521_f5c9b1c4-dbc6-4fa3-bc41-4ee4bf417eb5.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cold Relief LemonPELARGONIUM SIDOIDESSchwabe North America, Inc.f5c9b1c4-dbc6-4fa3-bc41-4ee4bf417eb52025-07-31WarningsExact identifier
ndc (product): 53499-6146

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53499-6146-05349961460010 PACKET in 1 CARTON (53499-6146-0) / 5 g in 1 PACKET10 packet2024-04-19NoNoCurrent