FDA.reportPublic FDA data

Sinus Congestion Headache

Product NDC
50845-0263
11-digit product format
508450263
Labeler code
50845
Product ID
50845-0263_6c71b14c-9ef4-47e9-8042-41d95a20453a
Type
HUMAN OTC DRUG
Nonproprietary name
Antimonium Tartaricum, Asafoetida, Baptisia Tinctoria, Echinacea (Angustifolia), Eupatorium Perfoliatum, Euphorbia Pilulifera, Hepar Sulphuris Calcareum, Hydrastis Canadensis, Iodium, Kali Bichromicum, Lachesis Mutus, Magnesia Carbonica, Mucosa Nasalis Suis, Pulsatilla (Pratensis), Pyrogenium, Silicea, Teucrium Marum
Dosage form
SPRAY
Route
ORAL
Labeler
Liddell Laboratories, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2020-04-24
Substance
ANTIMONY POTASSIUM TARTRATE; BAPTISIA TINCTORIA ROOT; CALCIUM SULFIDE; ECHINACEA ANGUSTIFOLIA WHOLE; EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHORBIA HIRTA FLOWERING TOP; FERULA ASSA-FOETIDA RESIN; GOLDENSEAL; IODINE; LACHESIS MUTA VENOM; MAGNESIUM CARBONATE; POTASSIUM DICHROMATE; PULSATILLA PRATENSIS WHOLE; RANCID BEEF; SILICON DIOXIDE; SUS SCROFA NASAL MUCOSA; TEUCRIUM MARUM WHOLE
Active strength
6; 3; 30; 3; 6; 6; 30; 30; 200; 200; 10; 30; 30; 200; 30; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [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
Sinus Congestion Headache
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ANTIMONY POTASSIUM TARTRATE6 [hp_X]/mL
BAPTISIA TINCTORIA ROOT3 [hp_X]/mL
CALCIUM SULFIDE30 [hp_X]/mL
ECHINACEA ANGUSTIFOLIA WHOLE3 [hp_X]/mL
EUPATORIUM PERFOLIATUM FLOWERING TOP6 [hp_X]/mL
EUPHORBIA HIRTA FLOWERING TOP6 [hp_X]/mL
FERULA ASSA-FOETIDA RESIN30 [hp_C]/mL
GOLDENSEAL30 [hp_C]/mL
IODINE200 [hp_C]/mL
LACHESIS MUTA VENOM200 [hp_C]/mL
MAGNESIUM CARBONATE10 [hp_X]/mL
POTASSIUM DICHROMATE30 [hp_X]/mL
PULSATILLA PRATENSIS WHOLE30 [hp_C]/mL
RANCID BEEF200 [hp_C]/mL
SILICON DIOXIDE30 [hp_C]/mL
SUS SCROFA NASAL MUCOSA12 [hp_X]/mL
TEUCRIUM MARUM WHOLE3 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiDL6OZ476V3, 5EF0HWI5WU, 1MBW07J51Q, VB06AV5US8, 1W0775VX6E, 6H89ZY31MR, W9FZA51AS1, ZW3Z11D0JV, 9679TC07X4, VSW71SS07I, 0E53J927NA, T4423S18FM, 8E272251DI, 29SUH5R3HU, ETJ7Z6XBU4, ID3Z1X61WY, 10464S0TAA

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50845-0263-22024-11-04C16284748780-1f386c64a-2ba8-0266-e053-dadaa90a7c1aDRUG FACTS:
50845-0263-22023-01-30C16284748780-1f386c64a-2ba8-0266-e053-dadaa90a7c1aDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50845-0263-1Sinus Congestion Headache30 mL in 1 BOTTLE, SPRAYSPRAY303
50845-0263-2Sinus Congestion Headache1 in 1 PACKAGESPRAY13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50845-0263SINUS CONGESTION HEADACHE (ANTIMONIUM TARTARICUM, ASAFOETIDA, BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), EUPATORIUM PERFOLIATUM, EUPHORBIA PILULIFERA, HEPAR SULPHURIS CALCAREUM, HYDRASTIS CANADENSIS, IODIUM, KALI BICHROMICUM, LACHESIS MUTUS, MAGNESIA CARBONICA, MUCOSA NASALIS SUIS, PULSATILLA (PRATENSIS), PYROGENIUM, SILICEA, TEUCRIUM MARUM) SPRAY [LIDDELL LABORATORIES, INC.]3Current NDC, Legacy NDC, 2 package rows20241105_debc7747-8664-4598-a862-e295188c4fca.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50845-0263-15084502630130 mL in 1 BOTTLE, SPRAY30 mlHistorical
50845-0263-2508450263021 BOTTLE, SPRAY in 1 PACKAGE (50845-0263-2) / 30 mL in 1 BOTTLE, SPRAY (50845-0263-1) 2020-04-240000-00-00NoNoCurrent