FDA.reportPublic FDA data

basic care allergy relief

Product NDC
72288-479
11-digit product format
722880479
Labeler code
72288
Product ID
72288-479_8238fd1b-5c6b-4c65-b530-4786232eaafb
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Amazon.com Services LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-07-28
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
basic care allergy relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 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
1049630Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7d237d37-21c7-476d-a8b7-d91ea1b472eeAvailable 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
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72288-479-782024-01-30C16284748780-11030e365-02ac-111a-e063-dadaa90a10e2Amazon Allergy Relief Drug Facts
72288-479-792024-01-30C16284748780-11030e365-02ac-111a-e063-dadaa90a10e2Amazon Allergy Relief Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72288-479-78basic care allergy relief1 in 1 CARTONTABLET15
72288-479-78basic care allergy relief100 in 1 BOTTLETABLET1005
72288-479-79basic care allergy relief400 in 1 BOTTLETABLET4005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72288-479BASIC CARE ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [AMAZON.COM SERVICES LLC]5Current NDC, Legacy NDC, 3 package rows20240722_7d237d37-21c7-476d-a8b7-d91ea1b472ee.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 66 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Safetussin PM Nighttime Cough reliefDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEKramer Laboratories33dd2245-9abd-4b32-ac76-0f45a54c0f332025-12-29WarningsExact identifier
application number: M012
Winco Foods Medicated Chest RubCAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOLWinCo Foods, LLCf54eb60d-c602-1272-e053-2995a90aa95a2025-12-28WarningsExact identifier
application number: M012
Gencare-Nasal Decongestant PEPHENYLEPHRINE HYDROCHLORIDEPioneer Life Sciences, LLCad4d74a8-a762-4378-9016-f7c83421073e2025-12-26WarningsExact identifier
application number: M012
Sorbutuss NRSORBUTUSSDextrum Laboratories Inc.304f1d5a-218c-51ae-e054-00144ff88e882025-12-26WarningsExact identifier
application number: M012
caring mill Cough drops CHERRYMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.274a28aa-00e9-8b9d-e063-6394a90ace2a2025-12-26WarningsExact identifier
application number: M012
Creamy Strawberry Flavor Cough DropCREAMY STRAWBERRY FLAVOR COUGH DROP WITH MENTHOL AND PECTINXiamen Kang Zhongyuan Biotechnology Co., Ltd.2749b83a-ea4f-d8ca-e063-6394a90a69b72025-12-26WarningsExact identifier
application number: M012
DISCOUNT DRUG MARTCOUGH DROPS CHERRYXiamen Kang Zhongyuan Biotechnology Co., Ltd.29f4a026-c4d2-2645-e063-6294a90aac582025-12-26WarningsExact identifier
application number: M012
DISCOUNT DRUG MARTCOUGH DROPS MENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.274a13b5-6fcb-70ed-e063-6394a90a7fb32025-12-26WarningsExact identifier
application number: M012
Honey Lemon Flavor Cough DropHONEY LEMON FLAVOR COUGH DROPXiamen Kang Zhongyuan Biotechnology Co., Ltd.274a4802-7c02-ccce-e063-6394a90ad71d2025-12-26WarningsExact identifier
application number: M012
DISCOUNT DRUG MARTCOUGH DROPS HONEY LEMONXiamen Kang Zhongyuan Biotechnology Co., Ltd.2749f353-9286-15b9-e063-6394a90a76932025-12-26WarningsExact identifier
application number: M012
Leader Cough Drops Vanilla HoneyMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.26a93c2c-a663-e3d1-e063-6394a90ad8592025-12-26WarningsExact identifier
application number: M012
Nite-Time COLD/FLU MedicineACETAMINOPHENAptaPharma Inc.344440bc-d810-4296-93ec-e6ae6673856b2025-12-26WarningsExact identifier
application number: M012
Nite-Time COLD/FLU Medicine CherryACETAMINOPHENAptaPharma Inc.87c2b823-ed88-44f3-8f6a-df30430b40f32025-12-26WarningsExact identifier
application number: M012
TUSSIN CFDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEAptaPharma Inc.c005c6cf-7891-463e-b65d-1129ad4bf6ec2025-12-26WarningsExact identifier
application number: M012
Childrens AllergyDIPHENHYDRAMINE HYDROCHLORIDEAptaPharma Inc.b2cef61f-ab54-4a20-a7f7-6d3da4754e8b2025-12-26WarningsExact identifier
application number: M012
CHILDRENS MUCUS RELIEF COUGH - CHERRY FLAVORDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINAptaPharma Inc.9ae6fe74-80cd-482a-b3b9-3acafd6708ec2025-12-26WarningsExact identifier
application number: M012
Tussin ExpectorantGUAIFENESINAptaPharma, Inc.ca8fa216-09c1-42b2-a95b-fa3d0f13363c2025-12-26WarningsExact identifier
application number: M012
Gencare DayTime Cold and Flu SoftgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEPioneer Life Sciences, LLCa9875dc9-6a27-413c-a2c7-68a86483ffc12025-12-26WarningsExact identifier
application number: M012
MUCUS RELIEFGUAIFENESIN 400 MGPioneer Life Sciences, LLC3b7e0ee7-4dda-4bbe-842c-6cbbc208acd52025-12-26WarningsExact identifier
application number: M012
MUCUS RELIEFGUAIFENESIN 400 MGPioneer Life Sciences, LLC0d604fc6-7bb9-4f7c-99cd-fdae4df4bb6f2025-12-26WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN7d237d37-21c7-476d-a8b7-d91ea1b472ee5
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD7d237d37-21c7-476d-a8b7-d91ea1b472ee5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72288-479-78722880479781 BOTTLE in 1 CARTON (72288-479-78) / 100 TABLET in 1 BOTTLE1 bottle2020-07-280000-00-00NoNoCurrent
72288-479-7972288047979400 TABLET in 1 BOTTLE (72288-479-79) 400 tablet2020-11-100000-00-00NoNoCurrent