FDA.reportPublic FDA data

Allergy Relief

Product NDC
55301-190
11-digit product format
553010190
Labeler code
55301
Product ID
55301-190_b9c2cd25-1050-468f-8241-d671130acce4
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
CAPSULE
Route
ORAL
Labeler
ARMY AND AIR FORCE EXCHANGE SERVICE
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1990-03-15
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 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 HYDROCHLORIDE25 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55301-190-08Allergy Relief2 in 1 CARTONCAPSULE217
55301-190-08Allergy Relief12 in 1 BLISTER PACKCAPSULE1217

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40ALLERGY RELIEF (DIPHENHYDRAMINE HCL) CAPSULE [ARMY AND AIR FORCE EXCHANGE SERVICE]3
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MALLERGY RELIEF (DIPHENHYDRAMINE HCL) CAPSULE [ARMY AND AIR FORCE EXCHANGE SERVICE]3
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8ALLERGY RELIEF (DIPHENHYDRAMINE HCL) CAPSULE [ARMY AND AIR FORCE EXCHANGE SERVICE]3
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHALLERGY RELIEF (DIPHENHYDRAMINE HCL) CAPSULE [ARMY AND AIR FORCE EXCHANGE SERVICE]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDALLERGY RELIEF (DIPHENHYDRAMINE HCL) CAPSULE [ARMY AND AIR FORCE EXCHANGE SERVICE]3
GELATININACTIVE INGREDIENT2G86QN327LALLERGY RELIEF (DIPHENHYDRAMINE HCL) CAPSULE [ARMY AND AIR FORCE EXCHANGE SERVICE]3
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GALLERGY RELIEF (DIPHENHYDRAMINE HCL) CAPSULE [ARMY AND AIR FORCE EXCHANGE SERVICE]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLERGY RELIEF (DIPHENHYDRAMINE HCL) CAPSULE [ARMY AND AIR FORCE EXCHANGE SERVICE]3
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TALLERGY RELIEF (DIPHENHYDRAMINE HCL) CAPSULE [ARMY AND AIR FORCE EXCHANGE SERVICE]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HALLERGY RELIEF (DIPHENHYDRAMINE HCL) CAPSULE [ARMY AND AIR FORCE EXCHANGE SERVICE]3
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHALLERGY RELIEF (DIPHENHYDRAMINE HCL) CAPSULE [ARMY AND AIR FORCE EXCHANGE SERVICE]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55301-190ALLERGY RELIEF (DIPHENHYDRAMINE HCL) CAPSULE [ARMY AND AIR FORCE EXCHANGE SERVICE]16Current NDC, Legacy NDC, 2 package rows20250215_97ed70a0-b692-4c12-90d6-72b3c87e554c.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 79 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cherry Sore Throat LozengeBENZOCAINEAmerican Sales49248a40-1ca3-6dd1-e054-00144ff88e882025-12-07WarningsExact identifier
application number: M012
Sugar Free Honey Lemon Cough DropsMENTHOLAmerican Sales4896cbd1-57dd-1fc6-e054-00144ff8d46c2025-12-07WarningsExact identifier
application number: M012
cherry throat relief lozengesBENZOCAINECintas Corporation49b25e9e-1d47-4a10-e054-00144ff8d46c2025-12-07WarningsExact identifier
application number: M012
cherry sore throat lozengeBENZOCAINECVS Pharmacy3c54974d-9d15-2fa1-e054-00144ff88e882025-12-07WarningsExact identifier
application number: M012
honey lemon sore throat lozengesBENZOCAINECVS Pharmacy3c55009c-4b3e-135e-e054-00144ff8d46c2025-12-07WarningsExact identifier
application number: M012
sugar free menthol cough dropsMENTHOLCVS Pharmacy3bdd24a8-3b44-00cd-e054-00144ff8d46c2025-12-07WarningsExact identifier
application number: M012
sugar free honey lemon cough dropsMENTHOLCVS Pharmacy3c125b3a-e58f-5c06-e054-00144ff88e882025-12-07WarningsExact identifier
application number: M012
CVS Menthol Cough DropsMENTHOLCVS Pharmacyde97d13b-bb67-d0e6-e053-2995a90aeb2c2025-12-07WarningsExact identifier
application number: M012
menthol cough dropsMENTHOLAmerican Sales34dd34d1-1a08-3470-e054-00144ff8d46c2025-12-06WarningsExact identifier
application number: M012
DOLOGENACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATEKramer Novis656ea9ba-c9cf-44c6-af40-b8ba292ce38a2025-12-05WarningsExact identifier
application number: M012
Afrin No Drip Severe CongestionOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLCa79b5541-864b-412a-a085-96986ed6af592025-12-05WarningsExact identifier
application number: M012
Afrin No Drip Extra MoisturizingOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC.346f32cb-74cb-4896-b770-76d5f829a17d2025-12-05WarningsExact identifier
application number: M012
Afrin No Drip Original Pump MistOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC.530b2d27-5883-489e-87fa-90b45eb93b3c2025-12-05WarningsExact identifier
application number: M012
Coricidin HBP Cough and Cold Cough Suppressant, AntihistamineCHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDEBayer HealthCare LLC.ee666963-e686-4374-b52b-a677f1cd41142025-12-05WarningsExact identifier
application number: M012
Afrin No-Drip Allergy SinusOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC3beb5839-7422-449d-e054-00144ff88e882025-12-05WarningsExact identifier
application number: M012
Coricidin HBP Nighttime Multi-Symptom ColdACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEBayer HealthCare LLC.513ca24f-1262-4a2d-e054-00144ff8d46c2025-12-05WarningsExact identifier
application number: M012
Afrin Severe CongestionOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC.a49a506e-aca2-4af0-a50b-dca2c031e61d2025-12-05WarningsExact identifier
application number: M012
Throat Coat Sweet Orange FennelMENTHOLTraditional Medicinals, Inc.a746cef4-1fb4-45cf-e053-2995a90a02c82025-12-05WarningsExact identifier
application number: M012
GuaifenesinGUAIFENESINHealth Pharma USA LLC31755594-3e1c-b290-e063-6394a90aba612025-12-05WarningsExact identifier
application number: M012
Tabcin Extra StrengthACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL,Pharmadel LLC0670c33e-8a3c-ae00-e063-6294a90a165b2025-12-05WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN97ed70a0-b692-4c12-90d6-72b3c87e554c17
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD97ed70a0-b692-4c12-90d6-72b3c87e554c17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55301-190-08553010190082 BLISTER PACK in 1 CARTON (55301-190-08) / 12 CAPSULE in 1 BLISTER PACK2 blister pack1990-03-150000-00-00NoNoCurrent