Sunmark

Product NDC: 49348-636
11-digit product format: 493480636
Labeler code: 49348
Product ID: 49348-636_29a2cbbe-88da-1498-e063-6394a90ac36c
Type: HUMAN OTC DRUG
Nonproprietary name: Loratadine
Dosage form: SOLUTION
Route: ORAL
Labeler: Strategic Sourcing Services LLC
Application: ANDA076805
Marketing category: ANDA
Marketing start: 2004-08-20
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 42.

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
A076805-001	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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Sunmark
Brand name suffix: childrens loratadine
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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ed94cba7-c2c4-4cbe-9021-f554a51d51f2	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49348-636-34	Sunmark childrens loratadine	120 mL in 1 BOTTLE	SOLUTION	120		3
49348-636-34	Sunmark childrens loratadine	1 in 1 CARTON	SOLUTION	1		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49348-636-34	ML - Milliliter	49348-636	334abf37-de89-426b-8c08-54950b515484	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Loratadine	ACTIVE INGREDIENT	7AJO3BO7QN	SUNMARK CHILDRENS LORATADINE (LORATADINE) SOLUTION [MCKESSON]	1
Loratadine	ACTIVE MOIETY	7AJO3BO7QN	SUNMARK CHILDRENS LORATADINE (LORATADINE) SOLUTION [MCKESSON]	1
citric acid monohydrate	INACTIVE INGREDIENT	2968PHW8QP	SUNMARK CHILDRENS LORATADINE (LORATADINE) SOLUTION [MCKESSON]	1
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	SUNMARK CHILDRENS LORATADINE (LORATADINE) SOLUTION [MCKESSON]	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	SUNMARK CHILDRENS LORATADINE (LORATADINE) SOLUTION [MCKESSON]	1
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	SUNMARK CHILDRENS LORATADINE (LORATADINE) SOLUTION [MCKESSON]	1
sodium metabisulfite	INACTIVE INGREDIENT	4VON5FNS3C	SUNMARK CHILDRENS LORATADINE (LORATADINE) SOLUTION [MCKESSON]	1
sucrose	INACTIVE INGREDIENT	C151H8M554	SUNMARK CHILDRENS LORATADINE (LORATADINE) SOLUTION [MCKESSON]	1
water	INACTIVE INGREDIENT	059QF0KO0R	SUNMARK CHILDRENS LORATADINE (LORATADINE) SOLUTION [MCKESSON]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49348-636	SUNMARK CHILDRENS LORATADINE (LORATADINE) SOLUTION [STRATEGIC SOURCING SERVICES LLC]	3	Current NDC, Legacy NDC, 2 package rows	20241222_ed94cba7-c2c4-4cbe-9021-f554a51d51f2.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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Loratadine	LORATADINE	Sun Pharmaceutical Industries, Inc.	12c8066a-3429-481e-b63a-7ea2b439a170	2026-07-14	Warnings	Exact identifier application applno (ANDA): 076805 application number: ANDA076805
Childrens Loratadine	LORATADINE	Sun Pharmaceutical Industries, Inc.	78e11f1c-c8a4-4b2a-b7dc-ae1b2dea26d0	2026-04-08	Warnings	Exact identifier application applno (ANDA): 076805 application number: ANDA076805
Childrens Loratadine Sugar Free	LORATADINE	Preferred Pharmaceuticals Inc.	23936948-71bf-4c18-9160-22b7075e675d	2026-01-15	Warnings	Exact identifier application applno (ANDA): 076805 application number: ANDA076805
Childrens Loratadine Sugar Free	LORATADINE	Walgreen Company	42a73448-104a-4c7f-aea0-cef44d15f5f1	2026-01-13	Warnings	Exact identifier application applno (ANDA): 076805 application number: ANDA076805
Childrens Loratadine Sugar Free	LORATADINE	H E B	d710b760-794e-490b-a413-c7b2ee5149b9	2025-08-14	Warnings	Exact identifier application applno (ANDA): 076805 application number: ANDA076805
Childrens Loratadine Sugar Free	LORATADINE	STRATEGIC SOURCING SERVICES LLC	809456dc-1d1c-42a7-b17f-e43dacde927f	2025-07-30	Warnings	Exact identifier application applno (ANDA): 076805 application number: ANDA076805
Loratadine	LORATADINE	STRATEGIC SOURCING SERVICES LLC	6ba7fc5d-81c4-482c-8b38-4a6587853a9f	2025-07-21	Warnings	Exact identifier application applno (ANDA): 076805 application number: ANDA076805
childrens allergy	LORATADINE	Publix Super Markets Inc	fa429380-019e-4ccd-8444-d5d931c4cc65	2025-07-15	Warnings	Exact identifier application applno (ANDA): 076805 application number: ANDA076805
Childrens Loratadine Sugar Free	LORATADINE	Sun Pharmaceutical Industries, Inc.	58eaab62-ac36-4080-8ded-9b472dddc617	2025-07-02	Warnings	Exact identifier application applno (ANDA): 076805 application number: ANDA076805
Sunmark childrens loratadine	LORATADINE	Strategic Sourcing Services LLC	ed94cba7-c2c4-4cbe-9021-f554a51d51f2	2024-12-19	Warnings	Exact identifier application applno (ANDA): 076805 application number: ANDA076805 ndc (product): 49348-636
Childrens Loratadine	LORATADINE	Strategic Sourcing Services LLC	280739e5-94e5-4d1e-ba65-2b4304cbac97	2024-12-19	Warnings	Exact identifier application applno (ANDA): 076805 application number: ANDA076805
Childrens Loratadine Sugar Free	LORATADINE	American Sales Company	6977d7e0-9d01-4f5e-8d55-98dabb719585	2024-12-09	Warnings	Exact identifier application applno (ANDA): 076805 application number: ANDA076805
Loratadine	LORATADINE	Cardinal Health, 110 dba LEADER	db9d2182-6bf1-424a-a144-f2694c47989f	2021-06-23	Warnings	Exact identifier application applno (ANDA): 076805 application number: ANDA076805
Good Neighbor Pharmacy Childrens Loratadine	LORATADINE	AmerisourceBergen	3ffc656a-90f9-4921-9c4f-840023b98433	2020-06-24	Warnings	Exact identifier application applno (ANDA): 076805 application number: ANDA076805
Good Neighbor Pharmacy Childrens Loratadine	LORATADINE	AmerisourceBergen	22d0714b-c1fe-4e77-92d8-aed3284813b4	2020-06-23	Warnings	Exact identifier application applno (ANDA): 076805 application number: ANDA076805

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
692783	loratadine 5 MG in 5 mL Oral Solution	PSN	ed94cba7-c2c4-4cbe-9021-f554a51d51f2	3
692783	loratadine 1 MG/ML Oral Solution	SCD	ed94cba7-c2c4-4cbe-9021-f554a51d51f2	3
692783	loratadine 5 MG per 5 ML Oral Solution	SY	ed94cba7-c2c4-4cbe-9021-f554a51d51f2	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49348-636-34	49348063634	1 BOTTLE in 1 CARTON (49348-636-34) / 120 mL in 1 BOTTLE	1 bottle	2012-11-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sunmark ® children's loratadine syrup	Strategic Sourcing Services LLC \| Taro Pharmaceuticals U.S.A., Inc. \| Taro Pharmaceutical Industries Ltd.	2024-12-19	HUMAN OTC DRUG LABEL	3