Contessa

Product NDC
60986-1014
11-digit product format
609861014
Labeler code
60986
Product ID
60986-1014_4953dfa8-3e5a-60ee-e063-6394a90abe37
Type
HUMAN OTC DRUG
Nonproprietary name
Alchemilla Vulgaris, Asperula Odorata, Chamomilla, Viola Odorata, Cinchona Officinalis, Mentha Piperita, Rosmarinus Officinalis, Valeriana Officinalis, Helonia Dioica, Agnus Castus, Ambra Grisea, Cimicifuga Racemosa, Convallaria Majalis, Crocus Sativus, Cyclamen Europaeum, Damiana, Hydrastis Canadensis, Caulophyllum Thalictroides, Lilium Tigrinum, Senecio Aureus, Staphysagria, Naja Tripudians
Dosage form
LIQUID
Route
ORAL
Labeler
Marco Pharma International LLC.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1992-03-01
Substance
ALCHEMILLA XANTHOCHLORA FLOWERING TOP; AMBERGRIS; BLACK COHOSH; CAULOPHYLLUM THALICTROIDES ROOT; CHAMAELIRIUM LUTEUM ROOT; CHASTE TREE; CINCHONA OFFICINALIS BARK; CONVALLARIA MAJALIS; CYCLAMEN PURPURASCENS TUBER; DELPHINIUM STAPHISAGRIA SEED; GALIUM ODORATUM; GOLDENSEAL; LILIUM LANCIFOLIUM FLOWERING TOP; MATRICARIA RECUTITA; MENTHA PIPERITA; NAJA NAJA VENOM; PACKERA AUREA; ROSMARINUS OFFICINALIS FLOWERING TOP; SAFFRON; TURNERA DIFFUSA LEAFY TWIG; VALERIAN; VIOLA ODORATA
Active strength
1; 3; 3; 4; 2; 3; 2; 3; 3; 4; 1; 3; 4; 1; 1; 8; 4; 1; 3; 3; 1; 1 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Contessa
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCHEMILLA XANTHOCHLORA FLOWERING TOP1 [hp_X]/100mL
AMBERGRIS3 [hp_X]/100mL
BLACK COHOSH3 [hp_X]/100mL
CAULOPHYLLUM THALICTROIDES ROOT4 [hp_X]/100mL
CHAMAELIRIUM LUTEUM ROOT2 [hp_X]/100mL
CHASTE TREE3 [hp_X]/100mL
CINCHONA OFFICINALIS BARK2 [hp_X]/100mL
CONVALLARIA MAJALIS3 [hp_X]/100mL
CYCLAMEN PURPURASCENS TUBER3 [hp_X]/100mL
DELPHINIUM STAPHISAGRIA SEED4 [hp_X]/100mL
GALIUM ODORATUM1 [hp_X]/100mL
GOLDENSEAL3 [hp_X]/100mL
LILIUM LANCIFOLIUM FLOWERING TOP4 [hp_X]/100mL
MATRICARIA RECUTITA1 [hp_X]/100mL
MENTHA PIPERITA1 [hp_X]/100mL
NAJA NAJA VENOM8 [hp_X]/100mL
PACKERA AUREA4 [hp_X]/100mL
ROSMARINUS OFFICINALIS FLOWERING TOP1 [hp_X]/100mL
SAFFRON3 [hp_X]/100mL
TURNERA DIFFUSA LEAFY TWIG3 [hp_X]/100mL
VALERIAN1 [hp_X]/100mL
VIOLA ODORATA1 [hp_X]/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9M289NKI69, XTC0D02P6C, K73E24S6X9, JTJ6HH6YEH, DQV54Y5H3U, 433OSF3U8A, S003A158SB, QHH4HVF5QE, G728143D8Q, 00543AP1JV, N8C4A9A49H, ZW3Z11D0JV, 6268MFA917, G0R4UBI2ZZ, 79M2M2UDA9, ZZ4AG7L7VM, 5WS1632J8W, 8JM482TI79, E849G4X5YJ, RQ2CFA7WWJ

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60986-1014-72020-12-30C16284748780-197449f38-c473-f6ea-e053-dbdaa90aa703Drug Facts
60986-1014-72019-11-13C16284748780-197449f38-c473-f6ea-e053-dbdaa90aa703Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60986-1014-7Contessa236 mL in 1 BOTTLE, GLASSLIQUID2365

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60986-1014CONTESSA (ALCHEMILLA VULGARIS, ASPERULA ODORATA, CHAMOMILLA, VIOLA ODORATA, CINCHONA OFFICINALIS, MENTHA PIPERITA, ROSMARINUS OFFICINALIS, VALERIANA OFFICINALIS, HELONIA DIOICA, AGNUS CASTUS, AMBRA GRISEA, CIMICIFUGA RACEMOSA, CONVALLARIA MAJALIS, CROCUS SATIVUS, CYCLAMEN EUROPAEUM, DAMIANA, HYDRASTIS CANADENSIS, CAULOPHYLLUM THALICTROIDES, LILIUM TIGRINUM, SENECIO AUREUS, STAPHYSAGRIA, NAJA TRIPUDIANS) LIQUID [MARCO PHARMA INTERNATIONAL LLC.]4Current NDC, Legacy NDC, 1 package rows20231207_5a8ae10c-87a4-4751-9885-d84b0cad574a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60986-1014-760986101407236 mL in 1 BOTTLE, GLASS (60986-1014-7) 236 ml2011-12-060000-00-00NoNoCurrent