dg health allergy relief

Product NDC
55910-629
Requested package NDC
55910-629-39
11-digit product format
559100629
Labeler code
55910
Product ID
55910-629_04cb4c6b-ba93-46a4-a245-0683e5fe8518
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Dolgencorp Inc
Application
ANDA202538
Marketing category
ANDA
Marketing start
2021-06-03
Substance
LORATADINE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage55910-62955910-629-39DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55910-62955910-629-39DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55910-62955910-629-39DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202538-001LORATADINELORATADINE10MGCAPSULE / ORAL2018-12-21

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-2184e616aacf4f…
2026-08-18 06:07:402026-07A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-2187673890dc5c…
2021-03-12 10:30 UTC2021-03A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-213f01610625f2…
2019-09-15 20:21 UTC2019-09A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-21b00525d2431f…
2019-07-19 19:46 UTC2019-07A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202538-001LORATADINE10MGCAPSULE / ORAL2018-12-21f41ea6bd6efb…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
dg health allergy relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7AJO3BO7QNInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
828269Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
086a0a53-7092-4dc8-9c5e-0bd78337fedfAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-629-39dg health allergy relief30 in 1 CARTONCAPSULE, LIQUID FILLED302
55910-629-39dg health allergy relief1 in 1 BLISTER PACKCAPSULE, LIQUID FILLED12
55910-629-52dg health allergy relief1 in 1 BLISTER PACKCAPSULE, LIQUID FILLED12
55910-629-52dg health allergy relief10 in 1 CARTONCAPSULE, LIQUID FILLED102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-629DG HEALTH ALLERGY RELIEF (LORATADINE) CAPSULE, LIQUID FILLED [DOLGENCORP INC]2Current NDC, Legacy NDC, 4 package rows20250321_086a0a53-7092-4dc8-9c5e-0bd78337fedf.zip

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 1 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
dg health allergy reliefLORATADINEDolgencorp Inc086a0a53-7092-4dc8-9c5e-0bd78337fedf2025-03-11WarningsExact identifier
application applno (ANDA): 202538
application number: ANDA202538
ndc (package): 55910-629-39
ndc (product): 55910-629
ndc11 (package): 55910062939
allergy reliefLORATADINEMeijer, Inc.14f3d1a2-eda7-432a-8fe0-5437b95bdde62025-02-14WarningsExact identifier
application applno (ANDA): 202538
application number: ANDA202538
topcare allergy reliefLORATADINETopco Associates LLC5cc2e469-9080-4beb-804d-187fc335ccdc2025-02-10WarningsExact identifier
application applno (ANDA): 202538
application number: ANDA202538
LORATADINELORATADINEBionpharma Inc.4fa705fb-859e-4046-b153-a8338c50a97d2024-12-23WarningsExact identifier
application applno (ANDA): 202538
application number: ANDA202538
Basic Care Allergy ReliefLORATADINEAmazon.com Services LLC2a834b33-5759-4e54-9adc-379310656dee2020-08-19WarningsExact identifier
application applno (ANDA): 202538
application number: ANDA202538
LORATADINELORATADINEBionpharma Inc.59bebce3-2b82-4521-a796-2d4c83bcf6692019-01-08WarningsExact identifier
application applno (ANDA): 202538
application number: ANDA202538

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828269loratadine 10 MG 24HR Oral CapsulePSN086a0a53-7092-4dc8-9c5e-0bd78337fedf2
828269loratadine 10 MG Oral CapsuleSCD086a0a53-7092-4dc8-9c5e-0bd78337fedf2
828269loratadine 10 MG 24HR Oral CapsuleSY086a0a53-7092-4dc8-9c5e-0bd78337fedf2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-629-395591006293930 BLISTER PACK in 1 CARTON (55910-629-39) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK30 blister pack2021-06-090000-00-00NoNoCurrent