Ulcer Drops

Product NDC
63083-2094
11-digit product format
630832094
Labeler code
63083
Product ID
63083-2094_69b22328-1e59-47c1-a8d7-8941e1c8ec1b
Type
HUMAN OTC DRUG
Nonproprietary name
Ulcer Drops
Dosage form
LIQUID
Route
ORAL
Labeler
Professional Complementary Health Formulas
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1984-08-15
Substance
ACTIVATED CHARCOAL; ARSENIC TRIOXIDE; BLACK MUSTARD SEED; COMFREY ROOT; DAIKON; ELYMUS REPENS ROOT; FU LING; GINGER; GLYCYRRHIZA GLABRA; GOLDENSEAL; HELICOBACTER PYLORI; PANICUM MILIACEUM WHOLE; PLANTAGO LANCEOLATA LEAF; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; STARCH, RICE
Active strength
6; 12; 2; 6; 2; 2; 2; 2; 2; 5; 30; 2; 2; 2; 2 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL
Pharmacologic classes
Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ulcer Drops 2094ULCER DROPSProfessional Complementary Health Formulas92cfc484-e3bc-4f04-a06a-3299c8522e322026-01-08WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

WARNINGS Severe or persistent symptoms may be a sign of a serious condition. Consult a doctor promptly if symptoms persist or are accompanied by a fever, vomiting, diarrhea, or loss of appetite. Keep out of the reach of children. In case of overdose, get medical help or contact a poison control center right away. If pregnant or breastfeeding, ask a healthcare professional before use. Keep out of the reach of children. If pregnant or breastfeeding, ask a healthcare professional before use.

Additional Listing Data#

Finished product
Yes
Brand name base
Ulcer Drops
Brand name suffix
2094
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYCYRRHIZA GLABRA6 [hp_X]/59mL
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE12 [hp_X]/59mL
STARCH, RICE2 [hp_X]/59mL
PANICUM MILIACEUM WHOLE6 [hp_X]/59mL
PLANTAGO LANCEOLATA LEAF2 [hp_X]/59mL
FU LING2 [hp_X]/59mL
DAIKON2 [hp_X]/59mL
BLACK MUSTARD SEED2 [hp_X]/59mL
ELYMUS REPENS ROOT2 [hp_X]/59mL
GINGER5 [hp_X]/59mL
GOLDENSEAL30 [hp_X]/59mL
ACTIVATED CHARCOAL2 [hp_X]/59mL
COMFREY ROOT2 [hp_X]/59mL
ARSENIC TRIOXIDE2 [hp_X]/59mL
HELICOBACTER PYLORI2 [hp_X]/59mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2788Z9758H, 70WT22SF4B, 4DGK8B7I3S, 072D7X60WS, 2YWL9J7EE8, XH37TWY5O4, 86R5J6D01D, 8LTY55LQ8D, 3IXW0F6P8W, C5529G5JPQ, ZW3Z11D0JV, 2P3VWU3H10, M9VVZ08EKQ, S7V92P67HO, U09W5JOL3Z

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63083-2094-22026-01-09C16284748780-11030e365-2cc4-111a-e063-dadaa90a10e2C94
63083-2094-22026-01-09C16284748780-11030e365-2cc4-111a-e063-dadaa90a10e2C94
63083-2094-22024-01-30C16284748780-11030e365-2cc4-111a-e063-dadaa90a10e2C94
63083-2094-22024-01-30C16284748780-11030e365-2cc4-111a-e063-dadaa90a10e2C94

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63083-2094-2Ulcer Drops209459 mL in 1 BOTTLE, DROPPERLIQUID592

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63083-2094ULCER DROPS 2094 (ULCER DROPS) LIQUID [PROFESSIONAL COMPLEMENTARY HEALTH FORMULAS]1Current NDC, Legacy NDC, 1 package rows20220216_92cfc484-e3bc-4f04-a06a-3299c8522e32.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63083-2094-26308320940259 mL in 1 BOTTLE, DROPPER (63083-2094-2) 59 ml1985-08-150000-00-00NoNoCurrent