Home NDC 36800-608 topcare childrens allergy
Product NDC 36800-608
11-digit product format 368000608
Labeler code 36800
Product ID 36800-608_3e49bf56-baef-4c33-a38b-a25794c15622
Type HUMAN OTC DRUG
Nonproprietary name loratadine
Dosage form SOLUTION
Route ORAL
Labeler Topco Associates LLC
Application ANDA075728
Marketing category ANDA
Marketing start 2020-07-08
Substance LORATADINE
Active strength 5 mg/5mL
NDC exclude flag No
Listing certified through 2026-12-31
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075728-001 LORATADINE LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A075728-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075728-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075728-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075728-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075728-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075728-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075728-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075728-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075728-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075728-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075728-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075728-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075728-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075728-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075728-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075728-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075728-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075728-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075728-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075728-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075728-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075728-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075728-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075728-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075728-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075728-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075728-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075728-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075728-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075728-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075728-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075728-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075728-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075728-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075728-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075728-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075728-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075728-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075728-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075728-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 f41ea6bd6efb…
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 topcare childrens allergy
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LORATADINE 5 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7AJO3BO7QN Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 692783 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 36800-608-26 topcare childrens allergy 1 in 1 CARTON SOLUTION 1 3 36800-608-26 topcare childrens allergy 120 mL in 1 BOTTLE SOLUTION 120 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-608 TOPCARE CHILDRENS ALLERGY (LORATADINE) SOLUTION [TOPCO ASSOCIATES LLC] 3 Current NDC, Legacy NDC, 2 package rows 20220318_6e175fae-05dd-45c2-b9ab-7d49369a3c05.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 2 of 2 · 22 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 36800-608-26 36800060826 1 BOTTLE in 1 CARTON (36800-608-26) / 120 mL in 1 BOTTLE 1 bottle 2020-07-08 0000-00-00 No No Current