FDA.reportPublic FDA data

Tecnu Rash Relief

Product NDC
51879-164
11-digit product format
518790164
Labeler code
51879
Product ID
51879-164_262faf81-08c6-99e0-e063-6394a90a186a
Type
HUMAN OTC DRUG
Nonproprietary name
Grindelia Robusta, Calendula officinalis
Dosage form
SPRAY
Route
TOPICAL
Labeler
Tec Laboratories Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2023-07-12
Substance
CALENDULA OFFICINALIS FLOWER; GRINDELIA HIRSUTULA FLOWERING TOP
Active strength
1; 1 [hp_X]/mL; [hp_X]/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tecnu Rash Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GRINDELIA HIRSUTULA FLOWERING TOP1 [hp_X]/mL
CALENDULA OFFICINALIS FLOWER1 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
IDB0NAZ6AIInternal UNII lookup
P0M7O4Y7YDInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ffc38ad5-d414-4e68-e053-6294a90aa840Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51879-164-06Tecnu Rash Relief177 mL in 1 BOTTLE, SPRAYSPRAY1773

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51879-164-06ML - Milliliter51879-1643caf2dcf-a5a6-4acc-b382-fd8aaacc10cb12025-11-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51879-164TECNU RASH RELIEF (GRINDELIA ROBUSTA, CALENDULA OFFICINALIS) SPRAY [TEC LABORATORIES INC.]3Current NDC, 1 package rows20241107_ffc38ad5-d414-4e68-e053-6294a90aa840.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
Tecnu Rash ReliefGRINDELIA ROBUSTA, CALENDULA OFFICINALISTec Laboratories Inc.ffc38ad5-d414-4e68-e053-6294a90aa8402024-11-05WarningsExact identifier
ndc (product): 51879-164

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51879-164-0651879016406177 mL in 1 BOTTLE, SPRAY (51879-164-06) 177 ml2023-07-12NoNoCurrent