AMAZON BASIC CARE ALLERGY RELIEF

Product NDC
72288-452
11-digit product format
722880452
Labeler code
72288
Product ID
72288-452_8384bd63-e175-419f-a626-8ae62e23f89d
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
Amazon.com Services LLC
Application
ANDA208314
Marketing category
ANDA
Marketing start
2024-05-15
Substance
LORATADINE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
A208314-001LORATADINELORATADINE10MGTABLET / ORAL2018-04-16

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 22:38:342026-08A208314-001LORATADINE10MGTABLET / ORAL2018-04-1684e616aacf4f…
2026-08-18 06:07:402026-07A208314-001LORATADINE10MGTABLET / ORAL2018-04-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208314-001LORATADINE10MGTABLET / ORAL2018-04-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208314-001LORATADINE10MGTABLET / ORAL2018-04-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A208314-001LORATADINE10MGTABLET / ORAL2018-04-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208314-001LORATADINE10MGTABLET / ORAL2018-04-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208314-001LORATADINE10MGTABLET / ORAL2018-04-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208314-001LORATADINE10MGTABLET / ORAL2018-04-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208314-001LORATADINE10MGTABLET / ORAL2018-04-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208314-001LORATADINE10MGTABLET / ORAL2018-04-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208314-001LORATADINE10MGTABLET / ORAL2018-04-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208314-001LORATADINE10MGTABLET / ORAL2018-04-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208314-001LORATADINE10MGTABLET / ORAL2018-04-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208314-001LORATADINE10MGTABLET / ORAL2018-04-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208314-001LORATADINE10MGTABLET / ORAL2018-04-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208314-001LORATADINE10MGTABLET / ORAL2018-04-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208314-001LORATADINE10MGTABLET / ORAL2018-04-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208314-001LORATADINE10MGTABLET / ORAL2018-04-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208314-001LORATADINE10MGTABLET / ORAL2018-04-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208314-001LORATADINE10MGTABLET / ORAL2018-04-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208314-001LORATADINE10MGTABLET / ORAL2018-04-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208314-001LORATADINE10MGTABLET / ORAL2018-04-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208314-001LORATADINE10MGTABLET / ORAL2018-04-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A208314-001LORATADINE10MGTABLET / ORAL2018-04-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208314-001LORATADINE10MGTABLET / ORAL2018-04-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208314-001LORATADINE10MGTABLET / ORAL2018-04-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208314-001LORATADINE10MGTABLET / ORAL2018-04-163f01610625f2…
2019-09-15 20:21 UTC2019-09A208314-001LORATADINE10MGTABLET / ORAL2018-04-16b00525d2431f…
2019-07-19 19:46 UTC2019-07A208314-001LORATADINE10MGTABLET / ORAL2018-04-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208314-001LORATADINE10MGTABLET / ORAL2018-04-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208314-001LORATADINE10MGTABLET / ORAL2018-04-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208314-001LORATADINE10MGTABLET / ORAL2018-04-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208314-001LORATADINE10MGTABLET / ORAL2018-04-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208314-001LORATADINE10MGTABLET / ORAL2018-04-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208314-001LORATADINE10MGTABLET / ORAL2018-04-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208314-001LORATADINE10MGTABLET / ORAL2018-04-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A208314-001LORATADINE10MGTABLET / ORAL2018-04-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A208314-001LORATADINE10MGTABLET / ORAL2018-04-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208314-001LORATADINE10MGTABLET / ORAL2018-04-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208314-001LORATADINE10MGTABLET / ORAL2018-04-16f41ea6bd6efb…

Additional Listing Data#

Finished product
Yes
Brand name base
AMAZON BASIC CARE ALLERGY RELIEF
Listing expiration
2027-12-31

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
311372Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
113da68e-f658-082a-e063-6294a90ad929Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72288-452-09AMAZON BASIC CARE ALLERGY RELIEF30 in 1 BOTTLETABLET303
72288-452-09AMAZON BASIC CARE ALLERGY RELIEF1 in 1 CARTONTABLET13
72288-452-19AMAZON BASIC CARE ALLERGY RELIEF90 in 1 BOTTLETABLET903
72288-452-19AMAZON BASIC CARE ALLERGY RELIEF1 in 1 CARTONTABLET13
72288-452-30AMAZON BASIC CARE ALLERGY RELIEF1 in 1 CARTONTABLET13
72288-452-30AMAZON BASIC CARE ALLERGY RELIEF300 in 1 BOTTLETABLET3003
72288-452-36AMAZON BASIC CARE ALLERGY RELIEF1 in 1 CARTONTABLET13
72288-452-36AMAZON BASIC CARE ALLERGY RELIEF365 in 1 BOTTLETABLET3653
72288-452-70AMAZON BASIC CARE ALLERGY RELIEF70 in 1 BOTTLETABLET703
72288-452-70AMAZON BASIC CARE ALLERGY RELIEF1 in 1 CARTONTABLET13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72288-452AMAZON BASIC CARE ALLERGY RELIEF (LORATADINE) TABLET [AMAZON.COM SERVICES LLC]2Current NDC, 10 package rows20240515_113da68e-f658-082a-e063-6294a90ad929.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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LoratadineLORATADINEYYBA CORP5a71de5c-a844-9dd4-e063-6294a90af0152026-09-01WarningsExact identifier
application applno (ANDA): 208314
application number: ANDA208314
AMAZON BASIC CARE ALLERGY RELIEFLORATADINEAmazon.com Services LLC113da68e-f658-082a-e063-6294a90ad9292026-08-28WarningsExact identifier
application applno (ANDA): 208314
application number: ANDA208314
ndc (product): 72288-452
LoratadineLORATADINEMajor Pharmaceuticals98e41ae1-677a-4583-9a0a-edba29ebbc302026-08-07WarningsExact identifier
application applno (ANDA): 208314
application number: ANDA208314
LoratadineLORATADINEKROGER COMPANYb96831f5-5e75-c526-e053-2995a90a36ad2026-05-04WarningsExact identifier
application applno (ANDA): 208314
application number: ANDA208314
CONTAC AllergyLORATADINEVespyr Brands LLC4587a61d-139e-2a5b-e063-6394a90a13112026-05-01WarningsExact identifier
application applno (ANDA): 208314
application number: ANDA208314
LoratadineLORATADINEPreferred Pharmaceuticals Inc.7ca5050a-328a-4aff-8954-58f092e3ed6b2026-04-21WarningsExact identifier
application applno (ANDA): 208314
application number: ANDA208314
LoratadineLORATADINECVS Pharmacy, Inc.3937f769-e8e2-4b32-8338-21b0a74a86972026-03-20WarningsExact identifier
application applno (ANDA): 208314
application number: ANDA208314
LoratadineLORATADINEAurobindo Pharma Limited4f4ffb72-f4e8-4617-8bc5-61e6de488a2d2025-11-12WarningsExact identifier
application applno (ANDA): 208314
application number: ANDA208314
LoratadineLORATADINEA-S Medication Solutionsc84c2696-0d55-48a2-9d32-ca6c9bc57aa22025-11-11WarningsExact identifier
application applno (ANDA): 208314
application number: ANDA208314
LoratadineLORATADINEA-S Medication Solutions26c19e5b-7288-41a2-baaf-b4af196301402025-11-10WarningsExact identifier
application applno (ANDA): 208314
application number: ANDA208314
365 Whole Foods Market LoratadineLORATADINEWhole Foods Market, Inc.bba4e7c8-db8e-4522-915c-48ee809e3bce2025-06-11WarningsExact identifier
application applno (ANDA): 208314
application number: ANDA208314
LoratadineLORATADINEWALGREEN CO.c016aad8-df83-99b0-e053-2a95a90a49cf2024-06-24WarningsExact identifier
application applno (ANDA): 208314
application number: ANDA208314
LoratadineLORATADINECardinal Healthc96dd1c9-85a0-0792-e053-2a95a90a22642024-06-14WarningsExact identifier
application applno (ANDA): 208314
application number: ANDA208314
ALLERGY RELIEF 10mgLORATADINEYYBA CORP6103cf98-40b1-4d27-8eb7-6f6a069497302024-01-03WarningsExact identifier
application applno (ANDA): 208314
application number: ANDA208314
LoratadineLORATADINEChain Drug Consortium, LLC21199958-ac67-4f72-8a8c-4d7d31fa9da42022-11-04WarningsExact identifier
application applno (ANDA): 208314
application number: ANDA208314
LoratadineLORATADINEMcLane Company, Inc.f988f9fb-463d-4aaa-b83d-54a3b114e5702022-11-04WarningsExact identifier
application applno (ANDA): 208314
application number: ANDA208314
LoratadineLORATADINEAurohealth LLC839e2e03-9ebb-4a44-b753-fb174bd361152022-11-03WarningsExact identifier
application applno (ANDA): 208314
application number: ANDA208314
LoratadineLORATADINEWinco Foods, LLC.2a6cf697-0084-4522-bc89-b3e0f96a598d2022-08-17WarningsExact identifier
application applno (ANDA): 208314
application number: ANDA208314
LoratadineLORATADINEBluePoint Laboratoriesadc506ed-7a7a-facc-e053-2a95a90ae1472022-06-20WarningsExact identifier
application applno (ANDA): 208314
application number: ANDA208314
LoratadineLORATADINEAurohealth LLCc6bfb54a-04d8-41c1-9fa9-5d4bae0a66d12022-06-18WarningsExact identifier
application applno (ANDA): 208314
application number: ANDA208314

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSN113da68e-f658-082a-e063-6294a90ad9293
311372loratadine 10 MG Oral TabletSCD113da68e-f658-082a-e063-6294a90ad9293
311372loratadine 10 MG 24 HR Oral TabletSY113da68e-f658-082a-e063-6294a90ad9293

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72288-452-09722880452091 BOTTLE in 1 CARTON (72288-452-09) / 30 TABLET in 1 BOTTLE1 bottle2024-05-15NoNoCurrent
72288-452-19722880452191 BOTTLE in 1 CARTON (72288-452-19) / 90 TABLET in 1 BOTTLE1 bottle2024-05-15NoNoCurrent
72288-452-30722880452301 BOTTLE in 1 CARTON (72288-452-30) / 300 TABLET in 1 BOTTLE1 bottle2024-05-15NoNoCurrent
72288-452-36722880452361 BOTTLE in 1 CARTON (72288-452-36) / 365 TABLET in 1 BOTTLE1 bottle2024-05-15NoNoCurrent
72288-452-70722880452701 BOTTLE in 1 CARTON (72288-452-70) / 70 TABLET in 1 BOTTLE1 bottle2026-03-18NoNoCurrent