FDA.reportPublic FDA data

NDC 10631-115-69 - Absorica

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
10631-115
Requested NDC
10631-115-69
Package NDCs from labels
10631-115-69, 10631-115-31
Manufacturer
Sun Pharmaceutical Industries, Inc. | Galephar Pharmaceutical Research Inc. | Ohm Laboratories Inc.
Effective date
2026-08-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
AbsoricaSun Pharmaceutical Industries, Inc. | Galephar Pharmaceutical Research Inc. | Ohm Laboratories Inc.2026-08-19HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10631-115-31Absorica3 in 1 BOXCAPSULE318
10631-115-69Absorica10 in 1 BLISTER PACKCAPSULE1018

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10631-115ABSORICA (ISOTRETINOIN) CAPSULE ABSORICA LD (ISOTRETINOIN) CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.]18Current NDC, Legacy NDC, 2 package rows20231003_3ef0cff8-19c1-4441-b780-fca6c7ee1615.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10631-115-31EA - Each10631-11515a9e9f4-3af6-4b66-b435-246ca42ca19612013-02-13
10631-115-69EA - Each10631-11589f8f781-7337-47a7-b431-5cd1b9f65e7012017-03-06

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 112 · 2,222 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
ISOTRETINOINISOTRETINOINAurobindo Pharma Limited4e8516dc-a3c6-4d8f-aa14-2c37c6c8f6e62026-09-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197844
rxcui: 197845
rxcui: 1547565
rxcui: 403930
rxcui: 197843
rxcui: 1547561
unii: EH28UP18IF
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
IsotretinoinISOTRETINOINAmneal Pharmaceuticals LLCc2917c3d-3499-48a0-ba53-120cb979195d2026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197844
rxcui: 197845
rxcui: 403930
rxcui: 197843
unii: EH28UP18IF
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
Calamine PlusCALAMINE, PRAMOXINE HYDROCHLORIDEKroger Company44fdd5a4-3cac-15e5-e063-6294a90adb522026-08-26WarningsExact identifier
unii: 1K09F3G675
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
IsotretinoinISOTRETINOINZydus Pharmaceuticals USA Inc.31f62a49-4c6d-4ce3-a0ca-d159562370b12026-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197844
rxcui: 197845
rxcui: 1547565
rxcui: 403930
rxcui: 197843
rxcui: 1547561
unii: EH28UP18IF
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: 6DC9Q167V3
Rohto Max StrengthNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companye4b49550-1ca3-4bd7-854d-409b53fa5e262026-08-20WarningsExact identifier
unii: 6OZP39ZG8H
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
IsotretinoinISOTRETINOINActavis Pharma, Inc.1cf11710-f966-4529-8e08-02175f588bca2026-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197844
rxcui: 197845
rxcui: 1547565
rxcui: 403930
rxcui: 197843
rxcui: 1547561
unii: EH28UP18IF
Absorica LDISOTRETINOINSun Pharmaceutical Industries, Inc.3ef0cff8-19c1-4441-b780-fca6c7ee16152026-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA211913
application number: NDA021951
ndc (package): 10631-133-31
ndc (package): 10631-002-31
ndc (package): 10631-117-31
ndc (package): 10631-005-31
ndc (package): 10631-115-31
ndc (package): 10631-003-31
ndc (package): 10631-007-31
ndc (package): 10631-116-69
ndc (package): 10631-004-31
ndc (package): 10631-118-31
ndc (package): 10631-006-31
ndc (package): 10631-133-69
ndc (package): 10631-118-69
ndc (package): 10631-134-31
ndc (package): 10631-134-69
ndc (package): 10631-115-69
ndc (package): 10631-117-69
ndc (package): 10631-116-31
ndc (product): 10631-007
ndc (product): 10631-117
ndc (product): 10631-134
ndc (product): 10631-115
ndc (product): 10631-004
ndc (product): 10631-002
ndc (product): 10631-005
ndc (product): 10631-003
ndc (product): 10631-116
ndc (product): 10631-133
ndc (product): 10631-006
ndc (product): 10631-118
ndc11 (package): 10631011569
rxcui: 2262714
rxcui: 2262727
rxcui: 1547563
rxcui: 2262731
rxcui: 1300016
rxcui: 2262729
rxcui: 1300014
rxcui: 2262713
rxcui: 197844
rxcui: 2262711
rxcui: 197845
rxcui: 1547565
rxcui: 1299203
rxcui: 403930
rxcui: 2262723
rxcui: 2262717
rxcui: 1300006
rxcui: 2262721
rxcui: 197843
rxcui: 1547567
rxcui: 2262725
rxcui: 2262715
rxcui: 1547561
rxcui: 2262719
spl id: a83b6e70-c01f-47c2-8aa3-e8c4148bafa6
spl set id: 3ef0cff8-19c1-4441-b780-fca6c7ee1615
unii: EH28UP18IF
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: 6DC9Q167V3
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: 6DC9Q167V3
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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