FDA.reportPublic FDA data

Allergy Relief

Product NDC
69452-452
11-digit product format
694520452
Labeler code
69452
Product ID
69452-452_4bd1057c-3ae7-5275-e063-6394a90af757
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
BIONPHARMA INC.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-10-01
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TC2D6JAD40Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1020477Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1f737b76-14b5-618a-e063-6294a90a19c2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69452-452-20Allergy Relief1 in 1 CARTONCAPSULE, LIQUID FILLED13
69452-452-20Allergy Relief100 in 1 BOTTLECAPSULE, LIQUID FILLED1003
69452-452-83Allergy Relief300 in 1 BOTTLECAPSULE, LIQUID FILLED3003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-452ALLERGY RELIEF (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [BIONPHARMA INC.]1Current NDC, 3 package rows20241003_1f737b76-14b5-618a-e063-6294a90a19c2.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 65 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy Relief Dye FreeDIPHENHYDRAMINE HYDROCHLORIDE 25MGWalgreens36ba3ff2-1965-aa56-e063-6294a90afe172025-12-31WarningsExact identifier
application number: M012
Sinus Congestion and Pain SevereACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCLWal-Mart Stores Incf51d1d52-39c2-4259-8b30-f9ac21edb2652025-12-31WarningsExact identifier
application number: M012
DurahistDEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCLPoly Pharmaceuticals, Inc.33d71863-5cac-669f-e063-6394a90a6f212025-12-30WarningsExact identifier
application number: M012
Chest Congestion ReliefGUAIFENESINRUGBY LABORATORIES51b088bc-b44f-44b9-a08e-133509a35a2c2025-12-30WarningsExact identifier
application number: M012
Chest Congestion Relief DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINRUGBY LABORATORIES60c9e493-f58c-45d6-bade-c952975124032025-12-30WarningsExact identifier
application number: M012
BIO-RYTUSSCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEAdvanced Generic Corporatione48e46e3-d3fa-4b25-8b07-bbecc4f0b64b2025-12-30WarningsExact identifier
application number: M012
AltitussDEXTROMETHORPHAN HBR, GUAIFENESINAlternative Pharmacal Corporatione4ac96f5-2a3a-42a8-8db5-80de4dcdbd442025-12-30WarningsExact identifier
application number: M012
BiocofDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HCLAdvanced Generic Corporation6ae6a0cb-b4fc-4e7d-aefc-6a52ca1ae3d62025-12-30WarningsExact identifier
application number: M012
Altipres PediatricDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLAdvanced Generic Corporation2a336896-a2f8-2a0c-e063-6294a90ae03a2025-12-30WarningsExact identifier
application number: M012
AltipresDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLAlternative Pharmacal Corporationc5a43107-3eb8-46bb-87bd-20deafe28c3f2025-12-30WarningsExact identifier
application number: M012
Mucus Relief DMDEXTROMETHORPHAN HBR, GUAIFENESINChain Drug Marketing Association, Inc.d02f32c1-716e-4753-abba-ff97c4dc9e222025-12-30WarningsExact identifier
application number: M012
NIGHTTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLKROGERa690f5c5-ff41-4072-e053-2995a90a8e552025-12-29WarningsExact identifier
application number: M012
NinjacofCHLOPHEDIANOL HCL AND PYRILAMINE MALEATECenturion Labs, LLCe2bca40f-9c27-ec8b-2ff0-ef9847ba20372025-12-29WarningsExact identifier
application number: M012
QUALITY CHOICECOUGH DROPS CHERRYXiamen Kang Zhongyuan Biotechnology Co., Ltd.23079194-b5e7-d5e6-e063-6394a90a4d8c2025-12-29WarningsExact identifier
application number: M012
QUALITY CHOICECOUGH DROPS HONEY LEMONXiamen Kang Zhongyuan Biotechnology Co., Ltd.2307db15-592b-138a-e063-6394a90a23a52025-12-29WarningsExact identifier
application number: M012
QUALITY CHOICE Cough Drops Vanilla HoneyCOUGH DROPS VANILLA HONEYXiamen Kang Zhongyuan Biotechnology Co., Ltd.23087ee3-26a0-e2b8-e063-6394a90abef42025-12-29WarningsExact identifier
application number: M012
QUALITY CHOICE Cough Drops Black Cherry SUGAR FREECOUGH DROPS BLACK CHERRY SUGAR FREEXiamen Kang Zhongyuan Biotechnology Co., Ltd.230883da-de48-68e9-e063-6394a90a927c2025-12-29WarningsExact identifier
application number: M012
QUALITY CHOICECOUGH DROPS VITAMIN CXiamen Kang Zhongyuan Biotechnology Co., Ltd.23086723-5718-6d02-e063-6394a90a03d22025-12-29WarningsExact identifier
application number: M012
QUALITY CHOICE Cough Drops Creamy StrawberryCOUGH DROPS CREAMY STRAWBERRYXiamen Kang Zhongyuan Biotechnology Co., Ltd.23085717-b2ee-175c-e063-6394a90a7f542025-12-29WarningsExact identifier
application number: M012
QUALITY CHOICECOUGH DROPS MENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.2307bbe9-7c8f-4eff-e063-6394a90af4c32025-12-29WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN1f737b76-14b5-618a-e063-6294a90a19c23
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD1f737b76-14b5-618a-e063-6294a90a19c23
1020477diphenhydramine HCl 50 MG Oral CapsuleSY1f737b76-14b5-618a-e063-6294a90a19c23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69452-452-20694520452201 BOTTLE in 1 CARTON (69452-452-20) / 100 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2024-10-01NoNoCurrent
69452-452-8369452045283300 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-452-83) 2026-03-02NoNoCurrent