Allergy Relief

Product NDC
41163-329
11-digit product format
411630329
Labeler code
41163
Product ID
41163-329_2e46a9aa-ff1b-4fda-aa1b-33aac03803c7
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
United Natural Foods, Inc. dba UNFI
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1990-03-02
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage41163-32941163-329-12DDiscontinued by firm2026-10-23

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
41163-329-08Allergy Relief12 in 1 BLISTER PACKTABLET, FILM COATED1218
41163-329-08Allergy Relief2 in 1 CARTONTABLET, FILM COATED218
41163-329-12Allergy Relief100 in 1 BOTTLETABLET, FILM COATED10018
41163-329-12Allergy Relief1 in 1 CARTONTABLET, FILM COATED118
41163-329-22Allergy Relief12 in 1 BLISTER PACKTABLET, FILM COATED1218
41163-329-22Allergy Relief4 in 1 CARTONTABLET, FILM COATED418

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41163-329-08EA - Each41163-329b55a5746-95a7-4b09-b675-0735a3c8a23c12023-05-05
41163-329-12EA - Each41163-329ecd24238-f405-4f3e-ac66-184f573fb7bd12016-06-14
41163-329-22EA - Each41163-329de5d2551-c8ae-4274-aff6-af86e35d083f12013-05-02

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-329ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [UNITED NATURAL FOODS, INC. DBA UNFI]17Current NDC, Legacy NDC, 6 package rows20241023_4517c7ef-156c-42b8-a2da-165e936f0837.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 109 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Viva Porru Chest RubCAMPHOR, MENTHOL, EUCALYPTUS OILMenper Distributors, Inc.0dfadfe3-9e40-0eee-e063-6294a90a00c32025-07-22WarningsExact identifier
application number: M012
leader childrens allergy reliefDIPHENHYDRAMINE HCLCardinal Health 110, LLC. dba Leader40d697b7-dc59-4d24-8d46-db635e01b9d52025-07-22WarningsExact identifier
application number: M012
Allergy ReliefCHLORPHENIRAMINE MALEATEChain Drug Consortium34005c55-3176-4f28-9a3b-7dc6fefd01fe2025-07-19WarningsExact identifier
application number: M012
Sinus Relief Daytime NighttimeACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCLKroger Company73a77a13-983b-4e65-bb3c-2ba5e9f33a3e2025-07-19WarningsExact identifier
application number: M012
QUALITY CHOICE No Drip Nasal MistOXYMETAZOLINE HYDROCHLORIDEQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)7cb6ad04-7847-46b9-b371-0a3473001c792025-07-18WarningsExact identifier
application number: M012
Nasal Decongestant Maximum StrengthPSEUDOEPHEDRINE HCLChain Drug Consortium270e9221-d305-4148-b523-741e02fe733f2025-07-18WarningsExact identifier
application number: M012
ACTISPEC PSEDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDEACTIPHARMA, LLC5def1555-87f4-41d5-8a5c-be560aa8f1e22025-07-17WarningsExact identifier
application number: M012
EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAYACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDEKenvue Brands LLC1a17b24a-8022-4e2f-e063-6294a90af2762025-07-17WarningsExact identifier
application number: M012
BULPOL Smoking PatchesMENTHOLJiashen International Trade Limited3a1cc0e1-fabf-52b9-e063-6394a90ae35e2025-07-17WarningsExact identifier
application number: M012
Ampigrin Ultra Forte NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEOPMX LLCe11e71c3-fe7c-77c7-e053-2995a90a34b22025-07-17WarningsExact identifier
application number: M012
NitecinACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEOPMX LLCdfb56532-6f72-1e4d-e053-2a95a90a1c052025-07-17WarningsExact identifier
application number: M012
tabcin NIGHTACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEOPMX LLC0b3ed2bb-88ed-699e-e063-6394a90ac0232025-07-17WarningsExact identifier
application number: M012
Pentrexcilina Night TimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEOPMX LLCe11e5c17-28f2-7186-e053-2995a90a51f62025-07-17WarningsExact identifier
application number: M012
Viro Flu PM ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEOPMX LLCe1553da8-3a89-e258-e053-2a95a90a47252025-07-17WarningsExact identifier
application number: M012
ACTICON PEDIATRICDEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDEACTIPHARMA, LLC3052cc67-e6c0-4d3f-9ec9-ffe58d9fae232025-07-17WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEDemoulas Super Markets, Inc397f5acd-31c0-683e-e063-6394a90a7e542025-07-16WarningsExact identifier
application number: M012
EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAY/NIGHTACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATEKenvue Brands LLC19ad2cca-c1cb-019c-e063-6294a90a56442025-07-16WarningsExact identifier
application number: M012
DG HEALTH COLD FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEDolgencorp Inc8ea03891-2fbc-4413-8e6d-de903d426f8d2025-07-16WarningsExact identifier
application number: M012
up and up nighttime flu and severe cold and coughACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDETarget Corporationdf488727-b913-440b-9a0b-cce3ae143bf22025-07-15WarningsExact identifier
application number: M012
Topcare DayTime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDETopco Associates LLCbb9663e3-fd11-4e72-bf85-fee4841b795f2025-07-15WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN4517c7ef-156c-42b8-a2da-165e936f083718
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD4517c7ef-156c-42b8-a2da-165e936f083718

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41163-329-08411630329082 BLISTER PACK in 1 CARTON (41163-329-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack1990-03-020000-00-00NoNoCurrent
41163-329-1241163032912100 in 1 BOTTLEHistorical
41163-329-22411630329224 BLISTER PACK in 1 CARTON (41163-329-22) / 12 TABLET, FILM COATED in 1 BLISTER PACK4 blister pack1990-03-020000-00-00NoNoCurrent