FDA.reportPublic FDA data

Free to Breathe

Product NDC
70994-109
Requested package NDC
70994-109-08
11-digit product format
709940109
Labeler code
70994
Product ID
70994-109_4604bf2b-6161-a5be-e063-6394a90a52a9
Type
HUMAN OTC DRUG
Nonproprietary name
Calendula, Eucalyptus,Peppermint
Dosage form
SALVE
Route
TOPICAL
Labeler
Spry Life LLC
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2020-03-06
Substance
CALENDULA OFFICINALIS FLOWER; EUCALYPTUS GLOBULUS LEAF; MENTHA PIPERITA
Active strength
1; 1.63; 1.63 [hp_X]/100g; g/100g; g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70994-10970994-109-08UExcluded because listing certification expiredexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70994-10970994-109-08UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

Additional Listing Data#

Finished product
Yes
Brand name base
Free to Breathe
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALENDULA OFFICINALIS FLOWER1 [hp_X]/100g
EUCALYPTUS GLOBULUS LEAF1.63 g/100g
MENTHA PIPERITA1.63 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
P0M7O4Y7YDInternal UNII lookup
S546YLW6E6Internal UNII lookup
79M2M2UDA9Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8d437d62-2cbc-5b17-e053-2a95a90ad5cbAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70994-109-01Free to Breathe1 in 1 BOXSALVE18
70994-109-02Free to Breathe51.7 g in 1 CANSALVE51.78
70994-109-04Free to Breathe17 g in 1 TUBESALVE178
70994-109-08Free to Breathe113.4 g in 1 JARSALVE113.48
70994-109-09Free to Breathe19.8 g in 1 CANSALVE19.88
70994-109-10Free to Breathe1 in 1 BOXSALVE18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70994-109FREE TO BREATHE (CALENDULA, EUCALYPTUS,PEPPERMINT) SALVE [SPRY LIFE LLC]7Current NDC, Legacy NDC, 6 package rows20250130_8d437d62-2cbc-5b17-e053-2a95a90ad5cb.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
Free to BreatheCALENDULA, EUCALYPTUS,PEPPERMINTSpry Life LLC8d437d62-2cbc-5b17-e053-2a95a90ad5cb2025-12-15WarningsExact identifier
ndc (package): 70994-109-08
ndc (product): 70994-109
ndc11 (package): 70994010908

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70994-109-0870994010908113.4 g in 1 JAR (70994-109-08) 113.4 g2020-03-060000-00-00NoNoCurrent