ALLERGY RELIEF

Product NDC: 49483-061
11-digit product format: 494830061
Labeler code: 49483
Product ID: 49483-061_385f6471-a79e-0c48-e063-6294a90af1a3
Type: HUMAN OTC DRUG
Nonproprietary name: DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: TIME CAP LABORATORIES, INC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2012-05-01
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: 2026-12-31
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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49483-061-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49483-061-65	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49483-061-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49483-061-42	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49483-061-62	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49483-061-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49483-061-65	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49483-061-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49483-061-42	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49483-061-62	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49483-061-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49483-061-65	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49483-061-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49483-061-42	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49483-061-62	`0efc9e666f02…`	`f202fb6c5f17…`

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: 2026-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1049630	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
7aee34b5-1583-4a8a-8ffb-b17ef2722ac1	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, Related label table
NDC	Effective	Related label
49483-061-01	2025-02-10	160R timely 49483-061 Diphenhydramine HCl 25mg
49483-061-10	2025-02-10	160R timely 49483-061 Diphenhydramine HCl 25mg
49483-061-42	2025-02-10	160R timely 49483-061 Diphenhydramine HCl 25mg
49483-061-62	2025-02-10	160R timely 49483-061 Diphenhydramine HCl 25mg
49483-061-65	2025-02-10	160R timely 49483-061 Diphenhydramine HCl 25mg
49483-061-01	2025-01-30	160R timely 49483-061 Diphenhydramine HCl 25mg
49483-061-10	2025-01-30	160R timely 49483-061 Diphenhydramine HCl 25mg
49483-061-42	2025-01-30	160R timely 49483-061 Diphenhydramine HCl 25mg
49483-061-62	2025-01-30	160R timely 49483-061 Diphenhydramine HCl 25mg
49483-061-65	2025-01-30	160R timely 49483-061 Diphenhydramine HCl 25mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
49483-061-01	ALLERGY RELIEF	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100	10
49483-061-10	ALLERGY RELIEF	1000 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	1000	10
49483-061-42	ALLERGY RELIEF	24 in 1 BOTTLE	TABLET, FILM COATED	24	10
49483-061-42	ALLERGY RELIEF	1 in 1 CARTON	TABLET, FILM COATED	1	10
49483-061-62	ALLERGY RELIEF	650 in 1 BOTTLE	TABLET, FILM COATED	650	10
49483-061-65	ALLERGY RELIEF	365 in 1 BOTTLE	TABLET, FILM COATED	365	10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	ALLER-G-TIME (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [TIME CAP LABORATORIES, INC]	4
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	ALLER-G-TIME (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [TIME CAP LABORATORIES, INC]	4
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	ALLER-G-TIME (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [TIME CAP LABORATORIES, INC]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ALLER-G-TIME (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [TIME CAP LABORATORIES, INC]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ALLER-G-TIME (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [TIME CAP LABORATORIES, INC]	4
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	ALLER-G-TIME (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [TIME CAP LABORATORIES, INC]	4
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	ALLER-G-TIME (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [TIME CAP LABORATORIES, INC]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ALLER-G-TIME (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [TIME CAP LABORATORIES, INC]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ALLER-G-TIME (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [TIME CAP LABORATORIES, INC]	4
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	ALLER-G-TIME (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [TIME CAP LABORATORIES, INC]	4
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	ALLER-G-TIME (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [TIME CAP LABORATORIES, INC]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ALLER-G-TIME (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [TIME CAP LABORATORIES, INC]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ALLER-G-TIME (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [TIME CAP LABORATORIES, INC]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49483-061	ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [TIME CAP LABORATORIES, INC]	9	Current NDC, Legacy NDC, 6 package rows	20250212_7aee34b5-1583-4a8a-8ffb-b17ef2722ac1.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 47 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Walgreen Company	c5cb09d4-c049-461c-8898-2c5bb6a8a138	2026-03-04	Warnings	Exact identifier application number: M012
Tussin CF	DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCL	WinCo Foods, LLC	3d96d6d0-8c04-43bb-aed0-4cd00cdf3456	2026-03-04	Warnings	Exact identifier application number: M012
DayTime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	H E B	e2994c0f-add8-4f75-a6d2-24cd2af271e4	2026-03-03	Warnings	Exact identifier application number: M012
NIGHTTIME CHERRY COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE	BETTER LIVING BRANDS LLC.	36924420-f514-4225-e063-6294a90a330c	2026-03-03	Warnings	Exact identifier application number: M012
Daytime Nighttime Ultra Concentrated	DAYTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND NIGHTTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	CVS HEALTH CORP	4584d701-5a4e-e54e-e063-6394a90a38d6	2026-03-03	Warnings	Exact identifier application number: M012
foster and thrive nighttime cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Sportpharm LLC	7bdfd2ef-bb99-41f5-97ae-3a02c994bddd	2026-03-03	Warnings	Exact identifier application number: M012
Medique at Home Decorel Forte	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Sportpharm LLC	d27b5976-8cc0-4d99-96f6-9069b786affd	2026-03-03	Warnings	Exact identifier application number: M012
Tusnel EX	GUAIFENESIN	A-S Medication Solutions	7f703c9c-2256-4524-9d31-c51919399d26	2026-03-03	Warnings	Exact identifier application number: M012
Cough Relief	DEXTROMETHORPHAN HBR	Best Choice (Valu Merchandisers Company)	f49f1e9a-07ac-443e-9df8-3281d5f35e78	2026-03-03	Warnings	Exact identifier application number: M012
berkley and jensen nasal	OXYMETAZOLINE HYDROCHLORIDE	BJWC	77cbe75d-4ed9-4a8b-91dc-1cc28af25508	2026-03-02	Warnings	Exact identifier application number: M012
childrens cold and cough relief dm	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	Walgreen Company	6c7c950d-ed48-4428-9e9e-73684cabc699	2026-02-28	Warnings	Exact identifier application number: M012
Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	The Kroger Co.	116146db-719f-4c48-8a8a-1120ea62b0d5	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	BIONPHARMA INC.	1f737b76-14b5-618a-e063-6294a90a19c2	2026-02-27	Warnings	Exact identifier application number: M012
WALGREENS NIGHTTIME ALLERGY RELIEF	DOXYLAMINE SUCCINATE	WALGREENS CO.	a3c7df98-4611-4b61-9c03-5e687364bf74	2026-02-27	Warnings	Exact identifier application number: M012
MEIJER Childrens Allergy Relief Chews	DIPHENHYDRAMINE HCL	MEIJER DISTRIBUTION INC	3368e081-a3b2-4c03-8bd1-05cc6af0391d	2026-02-27	Warnings	Exact identifier application number: M012
CVS PHARMACY Nighttime MS Flu Relief	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND DEXTROMETHOPHAN HBR	CVS PHARMACY	23cafaa1-34fe-4cef-960b-5f664ea32cb4	2026-02-27	Warnings	Exact identifier application number: M012
Tussin DM Cough and Chest	DEXTROMETHORPHAN HBR, GUAIFENESIN	WinCo Foods, LLC	402969c9-945c-44b7-b018-b62f427ce571	2026-02-26	Warnings	Exact identifier application number: M012
nasal original	OXYMETAZOLINE HYDROCHLORIDE	HyVee Inc	d997f264-1b4a-4cca-a282-bd9645d55bfd	2026-02-26	Warnings	Exact identifier application number: M012
Multi-Symptom Cold and Fever Childrens	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	CVS PHARMACY	2a569e47-3f17-4fc7-83d6-a3dddfd4987e	2026-02-25	Warnings	Exact identifier application number: M012
Cough and Chest Congestion DN, Cough DM Daytime, Nighttime	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	184059b7-9238-480e-be4a-ed105f13c19d	2026-02-25	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
1049630	diphenhydrAMINE HCl 25 MG Oral Tablet	PSN	7aee34b5-1583-4a8a-8ffb-b17ef2722ac1	10
1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	7aee34b5-1583-4a8a-8ffb-b17ef2722ac1	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49483-061-01	49483006101	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49483-061-01)		2018-12-17	0000-00-00	No	No	Current
49483-061-10	49483006110	1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49483-061-10)		2018-12-17	0000-00-00	No	No	Current
49483-061-42	49483006142	1 BOTTLE in 1 CARTON (49483-061-42) / 24 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2021-07-30		No	No	Current
49483-061-62	49483006162	650 TABLET, FILM COATED in 1 BOTTLE (49483-061-62)		2012-05-01	0000-00-00	No	No	Current
49483-061-65	49483006165	365 TABLET, FILM COATED in 1 BOTTLE (49483-061-65)		2022-02-21		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
160R timely 49483-061 Diphenhydramine HCl 25mg	TIME CAP LABORATORIES, INC \| TIME CAP LABORATORIES, INC. \| MARKSANS PHARMA LIMITED	2025-06-25	HUMAN OTC DRUG LABEL	10