ALLERGY RELIEF

Product NDC: 51316-931
11-digit product format: 513160931
Labeler code: 51316
Product ID: 51316-931_867d0ebd-e378-4e6c-9069-9768f521fb7d
Type: HUMAN OTC DRUG
Nonproprietary name: loratadine
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Application: ANDA076011
Marketing category: ANDA
Marketing start: 2025-10-06
Substance: LORATADINE
Active strength: 10 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 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
A076011-001	LORATADINE	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL			2003-09-29

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076011-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-09-29	`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: ALLERGY RELIEF
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LORATADINE	10 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
311373	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
31cb3c06-7e15-4000-b169-50b66c14b01b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51316-931-46	ALLERGY RELIEF	1 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	1	3
51316-931-46	ALLERGY RELIEF	10 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	10	3
51316-931-65	ALLERGY RELIEF	1 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	1	3
51316-931-65	ALLERGY RELIEF	30 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	30	3

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
loratadine	LORATADINE	Rite Aid Corporation	7b804f66-9323-4119-a856-1e6f08280781	2026-09-04	Warnings	Exact identifier application applno (ANDA): 076011 application number: ANDA076011
ALLERGY RELIEF	LORATADINE	Meijer, Inc.	190ecdc3-454a-4623-9e4a-09f4ab865084	2026-07-09	Warnings	Exact identifier application applno (ANDA): 076011 application number: ANDA076011
allergy relief	LORATADINE	Kroger Company	745d48f2-504d-4e3d-abf8-768d201cf814	2026-02-24	Warnings	Exact identifier application applno (ANDA): 076011 application number: ANDA076011
equate loratadine	LORATADINE	WALMART INC.	882dc99b-22d2-4f3e-8613-9ac8d9c5d910	2025-10-14	Warnings	Exact identifier application applno (ANDA): 076011 application number: ANDA076011
ALLERGY RELIEF	LORATADINE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	31cb3c06-7e15-4000-b169-50b66c14b01b	2025-10-06	Warnings	Exact identifier application applno (ANDA): 076011 application number: ANDA076011 ndc (product): 51316-931
non drowsy allergy relief	LORATADINE	Meijer Distribution Inc	4762c96e-d562-4f74-a275-8cba597987f9	2025-05-08	Warnings	Exact identifier application applno (ANDA): 076011 application number: ANDA076011
Basic Care Allergy Relief	LORATADINE	Amazon.com Services LLC	76e35b3f-3382-4e14-a25f-5544c75ff7c8	2024-11-05	Warnings	Exact identifier application applno (ANDA): 076011 application number: ANDA076011
dg health allergy relief	LORATADINE	Dolgencorp, LLC	04258018-3d57-46d7-9595-04786da3f51a	2022-10-13	Warnings	Exact identifier application applno (ANDA): 076011 application number: ANDA076011
signature care allergy relief	LORATADINE	Safeway	0a4b8eef-762e-42cc-84ee-0018a9a3be58	2022-04-04	Warnings	Exact identifier application applno (ANDA): 076011 application number: ANDA076011
Topcare Allergy Relief	LORATADINE	Topco Associates LLC	32f4e1d1-c830-4752-8251-bcc233bf03f6	2021-11-29	Warnings	Exact identifier application applno (ANDA): 076011 application number: ANDA076011
careone allergy relief	LORATADINE	American Sales Company	fdacfd88-eb85-4a33-9863-c6ff484fea4e	2021-11-15	Warnings	Exact identifier application applno (ANDA): 076011 application number: ANDA076011
good sense allergy relief	LORATADINE	L. Perrigo Company	a8f97128-3af8-493d-8e66-a1e07f594131	2021-07-14	Warnings	Exact identifier application applno (ANDA): 076011 application number: ANDA076011
dg health allergy relief	LORATADINE	Dolgencorp, LLC	c18c40ae-19c8-4699-842a-43a5c4c236d5	2021-06-22	Warnings	Exact identifier application applno (ANDA): 076011 application number: ANDA076011
good sense allergy relief	LORATADINE	L. Perrigo Company	3ef968b8-6732-4c80-b385-f471ed407817	2021-03-15	Warnings	Exact identifier application applno (ANDA): 076011 application number: ANDA076011
Basic Care Allergy Relief	LORATADINE	Amazon.com Services LLC	c22c9880-ed0e-48a7-a30e-41f0aed5a212	2020-09-03	Warnings	Exact identifier application applno (ANDA): 076011 application number: ANDA076011

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
311373	loratadine 10 MG 24HR Disintegrating Oral Tablet	PSN	31cb3c06-7e15-4000-b169-50b66c14b01b	3
311373	loratadine 10 MG Disintegrating Oral Tablet	SCD	31cb3c06-7e15-4000-b169-50b66c14b01b	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
51316-931-46	51316093146	10 BLISTER PACK in 1 CARTON (51316-931-46) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	10 blister pack	2025-10-06	No	No	Current
51316-931-65	51316093165	30 BLISTER PACK in 1 CARTON (51316-931-65) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	30 blister pack	2025-10-06	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CVS Pharmacy, Inc. Allergy Relief Drug Facts	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	2025-10-06	HUMAN OTC DRUG LABEL	3