FDA.reportPublic FDA data

Allergy Relief-D

Product NDC
37808-787
Requested package NDC
37808-787-35
11-digit product format
378080787
Labeler code
37808
Product ID
37808-787_36230417-8688-d9fd-e063-6394a90ac2e5
Type
HUMAN OTC DRUG
Nonproprietary name
LORATADINE AND PSEUDOEPHEDRINE SULFATE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
HEB
Application
ANDA218017
Marketing category
ANDA
Marketing start
2025-05-27
Substance
PSEUDOEPHEDRINE SULFATE; LORATADINE
Active strength
240; 10 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A218017-001LORATADINE AND PSEUDOEPHEDRINE SULFATELORATADINE; PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2024-05-14

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A218017-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2024-05-1484e616aacf4f…
2026-08-18 06:07:402026-07A218017-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2024-05-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218017-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2024-05-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218017-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2024-05-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A218017-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2024-05-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218017-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2024-05-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218017-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2024-05-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218017-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2024-05-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218017-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2024-05-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218017-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2024-05-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218017-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2024-05-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A218017-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2024-05-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A218017-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2024-05-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A218017-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2024-05-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A218017-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2024-05-141e350fbaab3a…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218017-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2024-05-14a50c72e98297…

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-D
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PSEUDOEPHEDRINE SULFATE240 mg/1
LORATADINE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
Y9DL7QPE6BInternal UNII lookup
7AJO3BO7QNInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1117562Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
36230417-8687-d9fd-e063-6394a90ac2e5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-787-07Allergy Relief-D5 in 1 BLISTER PACKTABLET, EXTENDED RELEASE51
37808-787-07Allergy Relief-D2 in 1 CARTONTABLET, EXTENDED RELEASE21
37808-787-35Allergy Relief-D3 in 1 CARTONTABLET, EXTENDED RELEASE31
37808-787-35Allergy Relief-D5 in 1 BLISTER PACKTABLET, EXTENDED RELEASE51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-787ALLERGY RELIEF-D (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [HEB]1Current NDC, 4 package rows20250529_36230417-8687-d9fd-e063-6394a90ac2e5.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy Relief-DLORATADINE AND PSEUDOEPHEDRINE SULFATEHEB36230417-8687-d9fd-e063-6394a90ac2e52025-05-27WarningsExact identifier
application applno (ANDA): 218017
application number: ANDA218017
ndc (package): 37808-787-35
ndc (product): 37808-787
ndc11 (package): 37808078735

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1117562pseudoephedrine sulfate 240 MG / loratadine 10 MG 24HR Extended Release Oral TabletPSN36230417-8687-d9fd-e063-6394a90ac2e51
111756224 HR loratadine 10 MG / pseudoephedrine sulfate 240 MG Extended Release Oral TabletSCD36230417-8687-d9fd-e063-6394a90ac2e51
1117562loratadine 10 MG / pseudoephedrine sulfate 240 MG 24 HR Extended Release Oral TabletSY36230417-8687-d9fd-e063-6394a90ac2e51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
37808-787-35378080787353 BLISTER PACK in 1 CARTON (37808-787-35) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK3 blister pack2025-05-27NoNoCurrent