FDA.reportPublic FDA data

NDC 0006-0033-10 - BELSOMRA

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
0006-0033
Requested NDC
0006-0033-10
Package NDCs from labels
0006-0033-10, 0006-0033-30, 0006-0033-13
Manufacturer
Merck Sharp & Dohme LLC
Effective date
2025-03-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
BELSOMRA - Merck Sharp & Dohme LLCMerck Sharp & Dohme LLC2025-03-10HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0006-0033-10BELSOMRA1 in 1 CASETABLET, FILM COATED121
0006-0033-10BELSOMRA10 in 1 BLISTER PACKTABLET, FILM COATED1021
0006-0033-13BELSOMRA1 in 1 CASETABLET, FILM COATED121
0006-0033-13BELSOMRA3 in 1 BLISTER PACKTABLET, FILM COATED321
0006-0033-30BELSOMRA3 in 1 CARTONTABLET, FILM COATED321

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0006-0033BELSOMRA (SUVOREXANT) TABLET, FILM COATED [MERCK SHARP & DOHME LLC]21Current NDC, Legacy NDC, 5 package rows20250323_e5b72731-1acb-45b7-9c13-290ad12d3951.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0006-0033-10EA - Each0006-0033833c1483-e6fe-4cc5-a2d1-65a74203de1412015-03-03
0006-0033-13EA - Each0006-003370f8791f-2671-4f52-bf24-eba64819c70f12018-03-08
0006-0033-30EA - Each0006-00338c7a90c9-68d9-4d3c-becf-d294ccd909dd12015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
suvorexantACTIVE INGREDIENT081L192FO9BELSOMRA (SUVOREXANT) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]4
suvorexantACTIVE MOIETY081L192FO9BELSOMRA (SUVOREXANT) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBELSOMRA (SUVOREXANT) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]4
COPOVIDONE K25-31INACTIVE INGREDIENTD9C330MD8BBELSOMRA (SUVOREXANT) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]4
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48BELSOMRA (SUVOREXANT) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDBELSOMRA (SUVOREXANT) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTBELSOMRA (SUVOREXANT) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357BELSOMRA (SUVOREXANT) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]4
hypromellosesINACTIVE INGREDIENT3NXW29V3WOBELSOMRA (SUVOREXANT) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]4
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XBELSOMRA (SUVOREXANT) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]4
magnesium stearateINACTIVE INGREDIENT70097M6I30BELSOMRA (SUVOREXANT) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]4
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPBELSOMRA (SUVOREXANT) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]4
triacetinINACTIVE INGREDIENTXHX3C3X673BELSOMRA (SUVOREXANT) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]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 1 of 103 · 2,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Rohto All-In-OneHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEThe Mentholatum Company43e690e4-b381-46e3-838c-33aef5bdadde2026-08-20WarningsExact identifier
unii: 3NXW29V3WO
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30HAMBLIN DERMATOLOGY5942e64c-416e-7525-e063-6394a90a28392026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Protect Tinted Mineral SunscreenBROAD SPECTRUM SPF30Opal Day Spa5943413a-48e1-0bdf-e063-6294a90a2fff2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30MedSpa By Beauty Bar LLC5943ba3d-688e-9e9c-e063-6294a90afa9a2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30CORBY, JR., TERRY L.594443fd-8e27-4ec6-e063-6294a90a3ff02026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: 3NXW29V3WO
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DR. SAMRAO'S OFFICE58b2ca35-11ed-d848-e063-6294a90a5b372026-08-11WarningsExact identifier
unii: 15FIX9V2JP
Dr. Shitong Photon Energy Eye Care LiquidTETRAHYDROZOLINE HCL 0.05% HYPROMELLOSE 0.3% DR. SHITONG PHOTON ENERGY EYE CARE LIQUIDWenzhou Yuyuan Pharmaceutical Co., Ltd.58ace434-55ef-17ef-e063-6294a90aa8782026-08-10WarningsExact identifier
unii: 3NXW29V3WO
Journee Firm Riche Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE AND ZINC OXIDEMerz North America, Inc.d4d4bfcf-3674-4847-8ad8-1716a8e821ae2026-08-10WarningsExact identifier
unii: 15FIX9V2JP
VEIRFOO Brightening Hydrating Antiwrinkle SunscreenTITANIUM DIOXIDE, OCTINOXATELCM TECHNOLOGY Co., Ltd4cbbf8aa-8910-b7e7-e063-6294a90a4f072026-08-07WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc37fee381-ce6b-4949-9a4a-778aa839fb842026-08-06WarningsExact identifier
unii: 15FIX9V2JP
Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEYOCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8%Lale Cosmetics LLC581fb0cd-c55d-d562-e063-6394a90a7f112026-08-03WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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