FDA.reportPublic FDA data

NDC 55111-643-79 - Omeprazole

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
55111-643
Requested NDC
55111-643-79
Package NDCs from labels
55111-643-30, 55111-643-01, 55111-643-05, 55111-643-79, 55111-643-78
Manufacturer
Proficient Rx LP
Effective date
2026-08-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Omeprazole - Proficient Rx LPProficient Rx LP2026-08-01HUMAN PRESCRIPTION DRUG LABEL
Omeprazole - Dr. Reddy's Laboratories Limited | Dr. Reddy's Laboratories Limited - FTO IIIDr. Reddy's Laboratories Limited | Dr. Reddy's Laboratories Limited - FTO III2026-03-02HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55111-643-01Omeprazole100 in 1 BOTTLECAPSULE, DELAYED RELEASE10034
55111-643-05Omeprazole500 in 1 BOTTLECAPSULE, DELAYED RELEASE50034
55111-643-30Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE3034
55111-643-78Omeprazole10 in 1 CARTONCAPSULE, DELAYED RELEASE1034
55111-643-79Omeprazole10 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE1034

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-643OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]30Current NDC, Legacy NDC, 5 package rows20240616_603d2d06-c5e8-4378-a422-8dca1a410af7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-643-01EA - Each55111-643494e577b-97a6-4012-afd1-f4208307ef8812026-03-17
55111-643-30EA - Each55111-643144bd8d5-7399-43a1-bdf3-74516a41819c12026-03-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OmeprazoleACTIVE INGREDIENTKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]15
OmeprazoleACTIVE MOIETYKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]15
D&C Red No. 28INACTIVE INGREDIENT767IP0Y5NHOMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]15
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDOMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]15
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAOMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]15
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTOMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]15
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]15
gelatinINACTIVE INGREDIENT2G86QN327LOMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]15
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE4OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]15
hypromellosesINACTIVE INGREDIENT3NXW29V3WOOMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]15
meglumineINACTIVE INGREDIENT6HG8UB2MUYOMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]15
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JOMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]15
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]15
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TOMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]15
propylene glycolINACTIVE INGREDIENT6DC9Q167V3OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]15
RAW SUGARINACTIVE INGREDIENT8M707QY5GHOMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]15
SHELLACINACTIVE INGREDIENT46N107B71OOMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]15
talcINACTIVE INGREDIENT7SEV7J4R1UOMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]15
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPOMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]15
triethyl citrateINACTIVE INGREDIENT8Z96QXD6UMOMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]15

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 43 of 121 · 2,404 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Facial Mineral Sunscreen SPF 40TITANIUM DIOXIDE, ZINC OXIDERSL89 LLC3532a6a2-dbb5-8111-e063-6294a90aeaeb2025-12-12Exact identifier
unii: 15FIX9V2JP
Tinted Daily Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDERSL89 LLC35338026-525a-d8b3-e063-6394a90a98f52025-12-12Exact identifier
unii: 15FIX9V2JP
Mineral Lip ProtectionTITANIUM DIOXIDE, ZINC OXIDERSL89 LLC3541971e-3664-a9f5-e063-6294a90ac2d22025-12-12Exact identifier
unii: 15FIX9V2JP
Prime Protection Sunscreen non tintedTITANIUM DIOXIDE, ZINC OXIDEKRISTI REDD ESTHETICS36608832-22d8-bc76-e063-6394a90abac62025-12-12Exact identifier
unii: 15FIX9V2JP
Prime Protection Sunscreen, tintedTITANIUM DIOXIDE, ZINC OXIDEKRISTI REDD ESTHETICS3660af9e-d60f-c33e-e063-6394a90a3a052025-12-12Exact identifier
unii: 15FIX9V2JP
Prime Protection Sunscreen, tintedTITANIUM DIOXIDE, ZINC OXIDEKRISTI REDD ESTHETICS3660e701-1373-eef4-e063-6394a90a61402025-12-12Exact identifier
unii: 15FIX9V2JP
sheer tinted sunscreenTITANIUM DIOXIDE, ZINC OXIDESARA ELIZABETH SKINCARE3b177c49-ed8c-42b9-e063-6294a90a82c62025-12-12WarningsExact identifier
unii: 15FIX9V2JP
Non-Tinted Matte Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESkin Philosophy by Kelly3581ab49-ef55-3743-e063-6394a90a3bd52025-12-12Exact identifier
unii: 15FIX9V2JP
Matte Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESkin Philosophy by Kelly3581cf33-3520-42f7-e063-6394a90a6f932025-12-12Exact identifier
unii: 15FIX9V2JP
Matte Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESkin Philosophy by Kelly3592b2c7-295a-7c60-e063-6394a90a387b2025-12-12Exact identifier
unii: 15FIX9V2JP
Sun Elegant Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDESKIN BY NESRIN3580ae10-1867-cb68-e063-6394a90a72df2025-12-12Exact identifier
unii: 15FIX9V2JP
PROTECTOR SOLAR NON-TINTED SPF SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEThe Beez Kneez Skin Care & Acne Clinic LLC358195c0-6d28-1ffe-e063-6394a90a60272025-12-12Exact identifier
unii: 15FIX9V2JP
Matte Velvet TintTITANIUM DIOXIDE, ZINC OXIDEBrent Loftis, D.O., Inc., A California Medical Corporation3583f860-664b-2658-e063-6394a90a38572025-12-12Exact identifier
unii: 15FIX9V2JP
SPF LipTITANIUM DIOXIDE, ZINC OXIDEBrent Loftis, D.O., Inc., A California Medical Corporation359297cd-10e2-6ddd-e063-6394a90a4aa02025-12-12Exact identifier
unii: 15FIX9V2JP
Matte Velvet TintTITANIUM DIOXIDE, ZINC OXIDEBrent Loftis, D.O., Inc., A California Medical Corporation359641c5-0e19-f243-e063-6394a90aeebc2025-12-12Exact identifier
unii: 15FIX9V2JP
TINTED MINERAL SUNSCREEN SPF 40TITANIUM DIOXIDE, ZINC OXIDEDERMATOLOGY ARTS35814d5d-fd34-05b3-e063-6294a90aadd12025-12-12Exact identifier
unii: 15FIX9V2JP
Tinted Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDELA HAIR DESIGN36eb4cd3-778c-362f-e063-6294a90a059c2025-12-11Exact identifier
unii: 15FIX9V2JP
Matte FinishTITANIUM DIOXIDE, ZINC OXIDECLEAN BEAUTY BY ANAK LLC37630c6c-f768-7b3e-e063-6394a90af5652025-12-11Exact identifier
unii: 15FIX9V2JP
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEADVANCED AESTHETICS SKIN CARE STUDIO, INC348fcc63-d8e3-90a1-e063-6294a90ade112025-12-11Exact identifier
unii: 15FIX9V2JP
SunscreenTITANIUM DIOXIDE, ZINC OXIDEScottsdale Skin Boutique Aesthetics Pllc34a49563-c74b-2fd1-e063-6394a90a6c562025-12-11Exact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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