FDA.reportPublic FDA data

Novarnica

Product NDC
61871-001
Requested package NDC
61871-001-01
11-digit product format
618710001
Labeler code
61871
Product ID
61871-001_e60f831b-b2ea-47d4-adbb-43b20ef6d440
Type
HUMAN OTC DRUG
Nonproprietary name
camphor and menthol
Dosage form
SPRAY
Route
TOPICAL
Labeler
Xcentrik Inc.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-01-22
Marketing end
0000-00-00
Substance
CAMPHOR (NATURAL); MENTHOL
Active strength
4 g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage61871-00161871-001-01IInactivated by FDA2026-09-14

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61871-001-012023-07-28C16284748780-10191ceaa-69d2-198a-e063-dbdaa90aec3e1944f4f0-1ff0-4421-8a54-7fd280588d2a
61871-001-022023-07-28C16284748780-10191ceaa-69d2-198a-e063-dbdaa90aec3e1944f4f0-1ff0-4421-8a54-7fd280588d2a

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61871-001-01Novarnica1 in 1 CARTONSPRAY18
61871-001-01Novarnica65 mL in 1 BOTTLESPRAY658
61871-001-02Novarnica120 mL in 1 BOTTLESPRAY1208
61871-001-02Novarnica1 in 1 CARTONSPRAY18

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAMPHOR (NATURAL)ACTIVE INGREDIENTN20HL7Q941NOVARNICA (CAMPHOR AND MENTHOL) SPRAY [XCENTRIK INC.]2
MENTHOLACTIVE INGREDIENTL7T10EIP3ANOVARNICA (CAMPHOR AND MENTHOL) SPRAY [XCENTRIK INC.]2
CAMPHOR (NATURAL)ACTIVE MOIETYN20HL7Q941NOVARNICA (CAMPHOR AND MENTHOL) SPRAY [XCENTRIK INC.]2
MENTHOLACTIVE MOIETYL7T10EIP3ANOVARNICA (CAMPHOR AND MENTHOL) SPRAY [XCENTRIK INC.]2
ARNICA MONTANA FLOWERINACTIVE INGREDIENTOZ0E5Y15PZNOVARNICA (CAMPHOR AND MENTHOL) SPRAY [XCENTRIK INC.]2
CLOVE OILINACTIVE INGREDIENT578389D6D0NOVARNICA (CAMPHOR AND MENTHOL) SPRAY [XCENTRIK INC.]2
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI662NOVARNICA (CAMPHOR AND MENTHOL) SPRAY [XCENTRIK INC.]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302NOVARNICA (CAMPHOR AND MENTHOL) SPRAY [XCENTRIK INC.]2
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JHNOVARNICA (CAMPHOR AND MENTHOL) SPRAY [XCENTRIK INC.]2
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHNOVARNICA (CAMPHOR AND MENTHOL) SPRAY [XCENTRIK INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RNOVARNICA (CAMPHOR AND MENTHOL) SPRAY [XCENTRIK INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61871-001NOVARNICA (CAMPHOR AND MENTHOL) SPRAY [XCENTRIK INC.]8Legacy NDC, 4 package rows20221221_1944f4f0-1ff0-4421-8a54-7fd280588d2a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043494camphor 4 % / menthol 8 % Topical SprayPSN1944f4f0-1ff0-4421-8a54-7fd280588d2a8
1043494camphor 40 MG/ML / menthol 80 MG/ML Topical SpraySCD1944f4f0-1ff0-4421-8a54-7fd280588d2a8
1043494camphor 4 % / menthol 8 % Topical SpraySY1944f4f0-1ff0-4421-8a54-7fd280588d2a8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61871-001-01618710001011 BOTTLE in 1 CARTON (61871-001-01) > 65 mL in 1 BOTTLE1 bottle2014-01-220000-00-00NoNoCurrent