FDA.reportPublic FDA data

NDC 0052-0602-01 - TICE BCG

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0052-0602
Requested NDC
0052-0602-01
Package NDCs from labels
0052-0602-01, 0052-0602-02
Manufacturer
Merck Sharp & Dohme LLC
Effective date
2026-02-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
TICE BCG - Merck Sharp & Dohme LLCMerck Sharp & Dohme LLC2026-02-20HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0052-0602-01TICE BCG50 mL in 1 VIALPOWDER, FOR SUSPENSION5022
0052-0602-02TICE BCG1 in 1 CARTONPOWDER, FOR SUSPENSION122

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0052-0602TICE BCG (BACILLUS CALMETTE-GUERIN) POWDER, FOR SUSPENSION [MERCK SHARP & DOHME LLC]20Current NDC, Legacy NDC, 2 package rows20241121_c9b74876-e665-442b-87ad-b7333bc9a67a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0052-0602-01EA - Each0052-060263e94ca0-99ed-48f0-ac75-6c0d1c5416a712018-07-03
0052-0602-02EA - Each0052-060220b6da70-5b8f-4d6c-885f-40f704f85bd612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGENACTIVE INGREDIENT2XQ558L16ZTICE BCG (BACILLUS CALMETTE-GUERIN) POWDER, FOR SUSPENSION [ORGANON USA INC.]4
BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGENACTIVE MOIETY2XQ558L16ZTICE BCG (BACILLUS CALMETTE-GUERIN) POWDER, FOR SUSPENSION [ORGANON USA INC.]4
ASPARAGINEINACTIVE INGREDIENT5Z33R5TKO7TICE BCG (BACILLUS CALMETTE-GUERIN) POWDER, FOR SUSPENSION [ORGANON USA INC.]4
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPTICE BCG (BACILLUS CALMETTE-GUERIN) POWDER, FOR SUSPENSION [ORGANON USA INC.]4
FERRIC AMMONIUM CITRATEINACTIVE INGREDIENTUVP74NG1C5TICE BCG (BACILLUS CALMETTE-GUERIN) POWDER, FOR SUSPENSION [ORGANON USA INC.]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTICE BCG (BACILLUS CALMETTE-GUERIN) POWDER, FOR SUSPENSION [ORGANON USA INC.]4
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GTICE BCG (BACILLUS CALMETTE-GUERIN) POWDER, FOR SUSPENSION [ORGANON USA INC.]4
MAGNESIUM SULFATEINACTIVE INGREDIENTDE08037SABTICE BCG (BACILLUS CALMETTE-GUERIN) POWDER, FOR SUSPENSION [ORGANON USA INC.]4
POTASSIUM PHOSPHATE, UNSPECIFIED FORMINACTIVE INGREDIENTB7862WZ632TICE BCG (BACILLUS CALMETTE-GUERIN) POWDER, FOR SUSPENSION [ORGANON USA INC.]4

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 4 of 23 · 449 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lemon GlycerinGLYCERINDynarex Corporation99fc00ea-9d55-0380-e053-2995a90a2c0b2026-03-24WarningsExact identifier
unii: PDC6A3C0OX
Optimel Manuka Dry Eye DropsGLYCERINMelcare Biomedical Pty Ltd88c5e2f0-9f7e-62d1-e053-2995a90a90142026-03-11WarningsExact identifier
unii: PDC6A3C0OX
Optimel Manuka Forte Eye GelGLYCERINMelcare Biomedical Pty Ltd8e0ed6e8-51fc-7c5b-e053-2a95a90a35a92026-03-11WarningsExact identifier
unii: PDC6A3C0OX
Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate OralSODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE ORALStrides Pharma Science Limitedd48d8c59-68b9-4e28-86a4-eabf8b2003b02026-03-10Warnings, Adverse reactionsExact identifier
unii: DE08037SAB
FleetGLYCERINC.B. Fleet Company, Inc.31778652-e60e-4098-8e90-3e4f56b5800c2026-03-06WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINBeijing Jingfeng Pharmaceutical (Shandong) Co., Ltd4c6094b7-c1ef-26a3-e063-6394a90af4cc2026-03-06WarningsExact identifier
unii: PDC6A3C0OX
Artificial TearsGLYCERINPreferred Pharmaceuticals Inc.dd646c72-8f47-43c6-a734-db0dcc8cd4d12026-03-06WarningsExact identifier
unii: PDC6A3C0OX
Dry Eye Relief Sterile Lubricant Eye DropsGLYCERINSimilasan Corporation4c4cce1c-392e-354d-e063-6294a90a0ca32026-03-05WarningsExact identifier
unii: PDC6A3C0OX
Sore ThroatPHENOL GLYCERINCVS PHARMACY, INC9683bcfb-2f7e-48a4-aa79-500ee8df099a2026-03-02WarningsExact identifier
unii: PDC6A3C0OX
Refresh Optive Mega-3 PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.326cb5d6-c784-404f-9a13-6d69262dda6e2026-03-01WarningsExact identifier
unii: PDC6A3C0OX
Dermatool HemorrhoidalGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLPapalo Group LLC4bc06f41-7733-ebd0-e063-6294a90af7a82026-02-26WarningsExact identifier
unii: PDC6A3C0OX
TricitratesTRICITRATESChartwell Governmental & Specialty RX, LLC.c4ff0407-3930-4c48-afd4-d2cb3e1b18f42026-02-25Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Potassium Citrate and Citric AcidPOTASSIUM CITRATE AND CITRIC ACIDChartwell Governmental & Specialty RX, LLC.fd57a176-7faf-4053-b348-6ba5f192f05a2026-02-25Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
TICE BCGBACILLUS CALMETTE-GUERINMerck Sharp & Dohme LLCc9b74876-e665-442b-87ad-b7333bc9a67a2026-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA102821
ndc (package): 0052-0602-01
ndc (package): 0052-0602-02
ndc (product): 0052-0602
ndc11 (package): 00052060201
rxcui: 213744
rxcui: 1653484
spl id: 223f2b2b-87d0-4beb-b00a-16a2b041a5bc
spl set id: c9b74876-e665-442b-87ad-b7333bc9a67a
unii: 2XQ558L16Z
WowDay Hemorrhoid and Fissure CreamHEMORRHOID AND FISSURE CREAMWowDay LLC47ba86ad-240a-e733-e063-6394a90a24e32026-02-12WarningsExact identifier
unii: PDC6A3C0OX
Viva Hydration BoostGLYCERINNomax Inc174193b2-65eb-b5fd-e063-6394a90a9cd02026-02-10WarningsExact identifier
unii: PDC6A3C0OX
Epsom SaltEPSOM SALTEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)1845ea0c-0cb6-482b-abe6-fa17785c5b902026-02-09WarningsExact identifier
unii: DE08037SAB
Epsom SaltMAGNESIUM SULFATESam's West, Inc6edb7688-0a64-4a7e-a0c0-9f75c96682fe2026-02-03WarningsExact identifier
unii: DE08037SAB
SUPREP Bowel PrepSODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATEAzurity Pharmaceuticals, Inc.50f23abd-6a66-44cb-960e-d43c16a5ae5f2026-01-31Warnings, Adverse reactionsExact identifier
unii: DE08037SAB
OptaseGLYCERINScope Health Inc376e0289-28e9-e87f-e063-6294a90a3b042026-01-30WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.