Allergy Relief

Product NDC
70000-0771
11-digit product format
700000771
Labeler code
70000
Product ID
70000-0771_00705d3f-bc14-40c4-9c1f-211a743ad2df
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
CARDINAL HEALTH 110, LLC. DBA LEADER
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-08-14
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

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 82 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alka-Seltzer Plus Maximum Strength Night Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.51dca689-e4a0-5526-e054-00144ff88e882025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Day Cold and Flu PowerMax GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.6f2d18f6-935f-9215-e053-2a91aa0aedd32025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu PowerMax GelsACETAMINOPHEN, DEXTRMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.6fb28fa1-ebbb-64bf-e053-2991aa0a1de42025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Severe Sinus, Allergy and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.5213ca7f-5a78-6471-e054-00144ff88e882025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Night Cold and Flu PowerMax GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.6f7ba256-ed14-5fe0-e053-2a91aa0aacc12025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu PowerMax GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATEBayer HealthCare LLC.6f7bf92d-4aaf-86e0-e053-2991aa0a2d912025-12-04WarningsExact identifier
application number: M012
Afrin NoDrip Allergy Sinus NightOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC.b023a571-7e54-7c63-e053-2a95a90a0f782025-12-04WarningsExact identifier
application number: M012
Coricidin HBP Cough and ColdCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROCHLORIDEBayer HealthCare LLC.b1cd7d9f-0ab4-21ce-e053-2a95a90a8c3d2025-12-04WarningsExact identifier
application number: M012
Children Afrin No Drip Extra Moisturizing Stuffy Nose Pump Mist Stuffy Nose Pump MistOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC.e3231869-8ddf-9d17-e053-2995a90ae6d52025-12-04WarningsExact identifier
application number: M012
Coricidin HBP Maximum Strength Multi Symptom FluACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEBayer HealthCare LLC.ae7cf41e-b618-d6bb-e053-2a95a90a66922025-12-04WarningsExact identifier
application number: M012
Afrin Allergy Sinus NasalOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC.c2d903bf-5c51-82d7-e053-2995a90aea492025-12-04WarningsExact identifier
application number: M012
Coricidin HBP Maximum Strength Cold, Cough and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEBayer HealthCare LLC.351d3c5c-05c8-921a-e063-6394a90abef92025-12-04WarningsExact identifier
application number: M012
Children Afrin Extra Moisturizing Stuffy Nose Pump Mist Stuffy Nose Pump MistOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC.e3b239bd-ffc7-600c-e053-2a95a90a3b3b2025-12-04WarningsExact identifier
application number: M012
Coricidin HBP Maximum Strength Cold Flu And Chest CongestionACETAMINOPHEN, GUAIFENESINBayer HealthCare LLC.de95d2dd-e766-f7ec-e053-2995a90afc5f2025-12-04WarningsExact identifier
application number: M012
Coricidin HBP Maximum Strength Cold and Flu Day and NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATEBayer HealthCare LLC.e4f3f906-2252-21d1-e053-2a95a90a85df2025-12-04WarningsExact identifier
application number: M012
Afrin No Drip Pump Mist Bundle PackOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC.16c52c79-baec-87db-e063-6294a90a3b3b2025-12-04WarningsExact identifier
application number: M012
Afrin Original Pump MistOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC.0f5ec576-f788-40aa-9088-0dd672e3cc7c2025-12-04WarningsExact identifier
application number: M012
Adult Long Lasting Cough ReliefDEXTROMETHORPHAN HBRShield Pharmaceuticals Corp432a79a9-c69d-4514-894a-7832e1b745ef2025-12-04WarningsExact identifier
application number: M012
GENCONTUSSCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEKRAMER NOVIS69d16d25-b09b-430e-8e01-0962d840dc212025-12-04WarningsExact identifier
application number: M012
Nasal Decongestant PEPHENYLEPHRINE HCLH E B7c04ab14-af28-4598-90ef-56ac11902c7d2025-12-04WarningsExact identifier
application number: M012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70000-0771-170000077101100 CAPSULE in 1 BOTTLE (70000-0771-1) 100 capsule2026-08-14NoNoCurrent
70000-0771-27000007710224 BLISTER PACK in 1 CARTON (70000-0771-2) / 1 CAPSULE in 1 BLISTER PACK24 blister pack2026-08-14NoNoCurrent