FDA.reportPublic FDA data

Benadryl Allergy Ultratab

Product NDC
73097-004
Requested package NDC
73097-004-40
11-digit product format
730970004
Labeler code
73097
Product ID
73097-004_518f4074-6307-3e46-e063-6294a90a8013
Type
HUMAN OTC DRUG
Nonproprietary name
DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Savings Distributors LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-07-03
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

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 · 19 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…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-278dfbde2a14a4…c9ff85d89658…

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
Benadryl Allergy Ultratab
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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049630Internal RxNorm lookup
1049632Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8d59d121-62a8-c43b-e053-2a95a90a5847Available 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
73097-004-022021-01-29C16284748780-1ba0f9c33-1d6f-a910-e053-dadaa90a0b85Benadryl Allergy Ultratab
73097-004-402021-01-29C16284748780-1ba0f9c33-1d6f-a910-e053-dadaa90a0b85Benadryl Allergy Ultratab
73097-004-502021-01-29C16284748780-1ba0f9c33-1d6f-a910-e053-dadaa90a0b85Benadryl Allergy Ultratab

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73097-004-02Benadryl Allergy Ultratab2 in 1 POUCHTABLET, FILM COATED23
73097-004-02Benadryl Allergy Ultratab1 in 1 CARTONTABLET, FILM COATED13
73097-004-40Benadryl Allergy Ultratab2 in 1 POUCHTABLET, FILM COATED23
73097-004-40Benadryl Allergy Ultratab20 in 1 CARTONTABLET, FILM COATED203
73097-004-50Benadryl Allergy Ultratab2 in 1 POUCHTABLET, FILM COATED23
73097-004-50Benadryl Allergy Ultratab25 in 1 CARTONTABLET, FILM COATED253

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73097-004BENADRYL ALLERGY ULTRATAB (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [SAVINGS DISTRIBUTORS LLC]1Current NDC, Legacy NDC, 6 package rows20190711_8d59d121-62a8-c43b-e053-2a95a90a5847.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 44 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equate Wild Cherry Throat DropPECTINWalmart4d66547a-b72a-a0ac-e063-6394a90adc712026-03-19WarningsExact identifier
application number: M012
Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATESafeway, Inc.45d44cd2-5187-4a5c-983a-edb1e8eba0b22026-03-19WarningsExact identifier
application number: M012
Sedalmex XL FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLBelmora LLCf2edfedf-e06e-4d1b-8c2d-732e08ec113c2026-03-19WarningsExact identifier
application number: M012
GuaifenesinGUAIFENESINBryant Ranch Prepack1e9887f6-209f-4f1f-9afa-a5ca649721cb2026-03-18WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLFamora Inc.5a7bf4cd-1d44-424d-9ef4-d484e626e3262026-03-18WarningsExact identifier
application number: M012
Harris Teeter Menthol Cough DropsMENTHOLHarris Teeter4d502c1f-7307-ac50-e063-6294a90a6ff42026-03-18WarningsExact identifier
application number: M012
Harris Teeter Cherry Cough DropsMENTHOLHarris Teeter4d50cc62-c84f-0761-e063-6394a90af54a2026-03-18WarningsExact identifier
application number: M012
Harris Teeter Honey Lemon Cough DropsMENTHOLHarris Teeter4d516fce-d219-eee9-e063-6294a90ac59a2026-03-18WarningsExact identifier
application number: M012
Harris Teeter SF Honey Lemon Cough DropsMENTHOLHarris Teeter4d524b45-260e-7411-e063-6294a90af6392026-03-18WarningsExact identifier
application number: M012
Guaifenesin and Dextromethorphan HydrobromideGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEBryant Ranch Prepack9a77465c-6d3a-4399-9734-ad22e4b435db2026-03-18WarningsExact identifier
application number: M012
good sense childrens cold coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEPreferred Pharmaceuticals Inc.a56d2fe4-5bea-4668-8e66-5a6f4279d4612026-03-18WarningsExact identifier
application number: M012
Mucus Relief DMDEXTROMETHORPHAN HBR, GUAIFENESINCardinal Health 110, LLC. DBA Leader4136e5f4-cc00-46d6-aa7f-ef56d087d7ec2026-03-18WarningsExact identifier
application number: M012
M-DrylDIPHENHYDRAMINE HYDROCHLORIDEBryant Ranch Prepackf9a0fb35-46d6-434f-8f9a-425a4bf50e842026-03-18WarningsExact identifier
application number: M012
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN AND CAFFEINEGrocery Outlet7398a372-7679-423b-a3ca-8da905a979dd2026-03-17WarningsExact identifier
application number: M012
Allergy ReliefALLERGY RELIEFGrocery Outlet0661ddeb-6289-471e-af89-7f4b7452c3552026-03-16WarningsExact identifier
application number: M012
Daytime Cold and Cough Nighttime Cold and CongestionBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLCVS2cf361eb-6055-2364-e063-6294a90a69a12026-03-16WarningsExact identifier
application number: M012
Severe Cold and Flu Relief Daytime/NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS PHARMACYb024ab38-e5da-4f5a-888f-e2a2815782902026-03-16WarningsExact identifier
application number: M012
good neighbor pharmacy night time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAmerisource Bergen41f87d59-3245-46dc-88a8-b947675a90fc2026-03-16WarningsExact identifier
application number: M012
Childrens Cold and CoughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN, PHENYLEPHRINE HCLCVS2bc3eae8-ffe6-bc96-e063-6394a90a22832026-03-16WarningsExact identifier
application number: M012
Daytime Nighttime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS HEALTH CORP23e2d2dc-12d4-294d-e063-6394a90a95232026-03-16WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049632Benadryl 25 MG Oral TabletPSN8d59d121-62a8-c43b-e053-2a95a90a58473
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN8d59d121-62a8-c43b-e053-2a95a90a58473
1049632diphenhydramine hydrochloride 25 MG Oral Tablet [Benadryl]SBD8d59d121-62a8-c43b-e053-2a95a90a58473
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD8d59d121-62a8-c43b-e053-2a95a90a58473
1049632Benadryl 25 MG Oral TabletSY8d59d121-62a8-c43b-e053-2a95a90a58473
1049632Benadryl Allergy Ultratab 25 MG Oral TabletSY8d59d121-62a8-c43b-e053-2a95a90a58473

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73097-004-407309700044020 POUCH in 1 CARTON (73097-004-40) / 2 TABLET, FILM COATED in 1 POUCH20 pouch2019-07-03NoNoCurrent