DYE-FREE CHILDRENS LORATADINE

Product NDC: 11673-111
11-digit product format: 116730111
Labeler code: 11673
Product ID: 11673-111_b9e6809c-e0ce-4205-98c5-665af1716503
Type: HUMAN OTC DRUG
Nonproprietary name: LORATADINE
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: UP & UP
Application: ANDA210088
Marketing category: ANDA
Marketing start: 2020-11-17
Substance: LORATADINE
Active strength: 5 mg/1
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 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A210088-001	LORATADINE	LORATADINE	5MG	TABLET, CHEWABLE / ORAL			2018-04-16
A210088-002	LORATADINE	LORATADINE	10MG	TABLET, CHEWABLE / ORAL			2025-04-25

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 · 45 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210088-002	LORATADINE	10MG	TABLET, CHEWABLE / ORAL	2025-04-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210088-002	LORATADINE	10MG	TABLET, CHEWABLE / ORAL	2025-04-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210088-002	LORATADINE	10MG	TABLET, CHEWABLE / ORAL	2025-04-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210088-001	LORATADINE	5MG	TABLET, CHEWABLE / ORAL	2018-04-16	`3a93d1ddd44b…`

Additional Listing Data#

Finished product: Yes
Brand name base: DYE-FREE CHILDRENS LORATADINE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LORATADINE	5 mg/1

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
665078	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
9660f7e6-3a29-4a6d-ba57-92088f624aa4	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
11673-111-30	DYE-FREE CHILDRENS LORATADINE	10 in 1 BLISTER PACK	TABLET, CHEWABLE	10		2
11673-111-30	DYE-FREE CHILDRENS LORATADINE	3 in 1 CARTON	TABLET, CHEWABLE	3		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11673-111	DYE-FREE CHILDRENS LORATADINE (LORATADINE) TABLET, CHEWABLE [UP & UP]	2	Current NDC, Legacy NDC, 2 package rows	20201124_9660f7e6-3a29-4a6d-ba57-92088f624aa4.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 · 38 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DYE-FREE LORATADINE	LORATADINE	Ohm Laboratories Inc.	48744daa-7079-283d-e063-6394a90a2c9a	2026-05-05	Warnings	Exact identifier application applno (ANDA): 210088 application number: ANDA210088
Dye-Free Childrens Loratadine	LORATADINE	CVS PHARMACY, INC	af6e6e60-8e39-45a8-bb76-50403aef9668	2026-03-11	Warnings	Exact identifier application applno (ANDA): 210088 application number: ANDA210088
DYE-FREE CHILDRENS LORATADINE	LORATADINE	WAL-MART STORES, INC	ec24da65-23c1-419d-9603-08348d3b9cc7	2025-04-04	Warnings	Exact identifier application applno (ANDA): 210088 application number: ANDA210088
CHILDRENS LORATADINE	LORATADINE	SAFEWAY	dad93ac1-ae0b-4918-8c62-92107e79a4b2	2024-12-29	Warnings	Exact identifier application applno (ANDA): 210088 application number: ANDA210088
Loratadine	LORATADINE	WALGREEN COMPANY	645c26ab-08ab-4a69-ae7d-7802d8ec5922	2024-12-29	Warnings	Exact identifier application applno (ANDA): 210088 application number: ANDA210088
Wal-itin	LORATADINE	Walgreens	176fe4f5-f72d-4fc2-bd9a-20626c9ab634	2024-12-27	Warnings	Exact identifier application applno (ANDA): 210088 application number: ANDA210088
Loratadine	LORATADINE	Premier Value	dc22862e-fe91-4900-8c2b-1ca45aeedbf0	2024-12-27	Warnings	Exact identifier application applno (ANDA): 210088 application number: ANDA210088
CHILDRENS LORATADINE	LORATADINE	TARGET CORPORATION	c02ad905-2363-4092-a90e-3be789112cb1	2024-12-27	Warnings	Exact identifier application applno (ANDA): 210088 application number: ANDA210088
Childrens Allergy	LORATADINE	TARGET CORPORATION	9507c223-ea75-477e-b765-f5d0bcba5ff9	2024-12-27	Warnings	Exact identifier application applno (ANDA): 210088 application number: ANDA210088
Loratadine	LORATADINE	WALGREENS CO.	c9e12155-a699-4fa7-aac8-da7d5ddab4ae	2024-11-19	Warnings	Exact identifier application applno (ANDA): 210088 application number: ANDA210088
Curist Childrens Allergy Relief	LORATADINE 5 MG CHEWABLE TABLETS	Little Pharma, Inc.	1ab6a653-0b7c-69d7-e063-6394a90aacad	2024-09-03	Warnings	Exact identifier application applno (ANDA): 210088 application number: ANDA210088
CHILDRENS LORATADINE	LORATADINE	TARGET CORPORATION	c5e87776-71e3-4c46-a8e7-30f47f437bef	2024-06-28	Warnings	Exact identifier application applno (ANDA): 210088 application number: ANDA210088
Dye-Free Childrens Loratadine	LORATADINE	UP & UP	85ea5c40-d02f-4c91-8eb2-4b16877e1eab	2024-06-28	Warnings	Exact identifier application applno (ANDA): 210088 application number: ANDA210088
Loratadine	LORATADINE	KROGER COMPANY	087ee83f-71aa-3d47-e063-6394a90aed4d	2024-05-08	Warnings	Exact identifier application applno (ANDA): 210088 application number: ANDA210088
DYE-FREE CHILDRENS LORATADINE	LORATADINE	Ohm Laboratories Inc.	10b0e325-335b-05b6-e063-6394a90a8c2f	2024-03-15	Warnings	Exact identifier application applno (ANDA): 210088 application number: ANDA210088
Dye-Free Childrens Loratadine	LORATADINE	Ohm Laboratories Inc.	9e9b2e1c-f565-42ef-9ec4-43bcebc549b7	2024-03-15	Warnings	Exact identifier application applno (ANDA): 210088 application number: ANDA210088
Dye-Free Childrens Loratadine	LORATADINE	CVS PHARMACY, INC	0b78fed4-69eb-f66f-e063-6294a90a3b89	2024-03-15	Warnings	Exact identifier application applno (ANDA): 210088 application number: ANDA210088
CHILDRENS LORATADINE	LORATADINE	SAFEWAY	0e0fbbf7-a42e-e101-e063-6294a90a6977	2024-03-15	Warnings	Exact identifier application applno (ANDA): 210088 application number: ANDA210088
Wal-itin	LORATADINE	WALGREENS CO.	fb9608d9-b401-40d9-aff3-2bc0dc6e92d8	2024-03-15	Warnings	Exact identifier application applno (ANDA): 210088 application number: ANDA210088
DYE-FREE CHILDRENS LORATADINE	LORATADINE	PUBLIX SUPER MARKETS, INC	0b29afdc-3b0f-3958-e063-6394a90a233a	2024-03-15	Warnings	Exact identifier application applno (ANDA): 210088 application number: ANDA210088

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7AJO3BO7QN	LORATADINE	79794-75-5	LORATADINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
665078	loratadine 5 MG 24HR Chewable Tablet	PSN	9660f7e6-3a29-4a6d-ba57-92088f624aa4	2
665078	loratadine 5 MG Chewable Tablet	SCD	9660f7e6-3a29-4a6d-ba57-92088f624aa4	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
11673-111-30	11673011130	3 BLISTER PACK in 1 CARTON (11673-111-30) / 10 TABLET, CHEWABLE in 1 BLISTER PACK	3 blister pack	2020-11-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dye-Free Children's Loratadine Chewable Tablets USP, 5 mg	UP & UP \| Ohm Laboratories Inc.	2020-11-19	HUMAN OTC DRUG LABEL	2