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 date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	`8dfbde2a14a4…`	`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
Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
TC2D6JAD40	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
8d59d121-62a8-c43b-e053-2a95a90a5847	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
73097-004-02	2021-01-29	C162847	48780-1	ba0f9c33-1d6f-a910-e053-dadaa90a0b85	Benadryl Allergy Ultratab
73097-004-40	2021-01-29	C162847	48780-1	ba0f9c33-1d6f-a910-e053-dadaa90a0b85	Benadryl Allergy Ultratab
73097-004-50	2021-01-29	C162847	48780-1	ba0f9c33-1d6f-a910-e053-dadaa90a0b85	Benadryl Allergy Ultratab

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
73097-004-02	Benadryl Allergy Ultratab	2 in 1 POUCH	TABLET, FILM COATED	2	3
73097-004-02	Benadryl Allergy Ultratab	1 in 1 CARTON	TABLET, FILM COATED	1	3
73097-004-40	Benadryl Allergy Ultratab	2 in 1 POUCH	TABLET, FILM COATED	2	3
73097-004-40	Benadryl Allergy Ultratab	20 in 1 CARTON	TABLET, FILM COATED	20	3
73097-004-50	Benadryl Allergy Ultratab	2 in 1 POUCH	TABLET, FILM COATED	2	3
73097-004-50	Benadryl Allergy Ultratab	25 in 1 CARTON	TABLET, FILM COATED	25	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
73097-004	BENADRYL ALLERGY ULTRATAB (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [SAVINGS DISTRIBUTORS LLC]	1	Current NDC, Legacy NDC, 6 package rows	20190711_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 30 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mucinex Fast-Max Severe Congestion and Cough	GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE	Reckitt Benckiser LLC	1991d5ee-fc90-4070-8965-cd6f4abc45cf	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Severe Congestion and Cough and Mucinex Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	3b2bb6d0-c5fa-3bfa-e063-6294a90a7afc	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Fast-Max DM Max and Mucinex Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	3ba2cc08-acad-79a8-e063-6394a90af17f	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Cold, Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	a3523aa3-9ed1-472d-9986-438440d0a3eb	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Fast-Max DM Max and Mucinex Nightshift Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	2ed3c844-0532-40d9-beba-738d196de34d	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Sinus-Max Severe Congestion and Pain	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	1e243dbe-138f-4346-ba22-ceea01e97052	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Nightshift Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	a14bc0d1-9b05-4a21-aaa8-95d4d073b9ed	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Sinus-Max Severe Congestion Relief	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	128f3442-9802-4303-80be-aead09237936	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Rapid Clear Pain, Headache, and Mucus Congestion and Sinus Max Clear and Cool	OXYMETAZOLINE HYDROCHLORIDE, ACETAMINOPHEN AND GUAIFENESIN	Reckitt Benckiser LLC	33f0d9bb-c67d-92ba-e063-6294a90a9943	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Sinus-Max Severe Congestion and Pain, Maximum Strength	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	2c01962d-74e3-4dfa-b7cb-a91a687711d5	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Sinus-Max Pressure, Pain and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	f5365c6d-9296-41a5-953a-d1008954e67f	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Sinus-Max Pressure, Pain and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	8905706b-b9da-4520-8cf2-87d7c125edf3	2026-05-13	Warnings	Exact identifier application number: M012
MUCINEX Rapid Clear Day Night and Clear and Cool Nasal	ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, TRIPROLIDINE HYDROCHLORIDE, AND OXYMETAZOLINE HYDROCHLORIDE	Reckitt Benckiser LLC	37dcb0ed-df56-1bec-e063-6394a90a695e	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Rapid Clear Pain, Headache, and Mucus Congestion and Sinus Max Clear and Cool	OXYMETAZOLINE HYDROCHLORIDE, ACETAMINOPHEN AND GUAIFENESIN	Reckitt Benckiser LLC	373e0d75-8def-4b98-e063-6394a90a5e47	2026-05-13	Warnings	Exact identifier application number: M012
MUCINEX SINUS-MAX SEVERE NASAL CONGESTION RELIEF CLEAR and COOL NASAL	OXYMETAZOLINE HYDROCHLORIDE	Reckitt Benckiser LLC	5a397466-8721-4060-a178-5ebfd7069cc9	2026-05-13	Warnings	Exact identifier application number: M012
Maximum Strength Mucinex Sinus-Max Pressure, Pain and Cough	ACETAMINOPHEN, GUAIFENESIN	Reckitt Benckiser LLC	350764de-7801-b24e-e063-6394a90ab3c3	2026-05-13	Warnings	Exact identifier application number: M012
Cepacol Extra Strength Sore Throat and Cough	BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE	Reckitt Benckiser LLC	c0cc32db-90f0-4106-8538-89821083ece1	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Nightshift Cold and Flu Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	316b5569-b66f-f30c-e063-6394a90ae147	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Nightshift Cold and Flu Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	d9467ca2-df75-4fa1-92b3-d2101eb54a77	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Nightshift Severe Cold and Flu Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	12420092-3ef6-464b-9106-2d56cd6ef200	2026-05-13	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
TC2D6JAD40	DIPHENHYDRAMINE HYDROCHLORIDE	147-24-0	DIPHENHYDRAMINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1049632	Benadryl 25 MG Oral Tablet	PSN	8d59d121-62a8-c43b-e053-2a95a90a5847	3
1049630	diphenhydrAMINE HCl 25 MG Oral Tablet	PSN	8d59d121-62a8-c43b-e053-2a95a90a5847	3
1049632	diphenhydramine hydrochloride 25 MG Oral Tablet [Benadryl]	SBD	8d59d121-62a8-c43b-e053-2a95a90a5847	3
1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	8d59d121-62a8-c43b-e053-2a95a90a5847	3
1049632	Benadryl 25 MG Oral Tablet	SY	8d59d121-62a8-c43b-e053-2a95a90a5847	3
1049632	Benadryl Allergy Ultratab 25 MG Oral Tablet	SY	8d59d121-62a8-c43b-e053-2a95a90a5847	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
73097-004-40	73097000440	20 POUCH in 1 CARTON (73097-004-40) / 2 TABLET, FILM COATED in 1 POUCH	20 pouch	2019-07-03	No	No	Current