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 26 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
dg health cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Dolgencorp Inc	ddcc1e78-4ea8-4489-88e7-86ff46016464	2026-05-21	Warnings	Exact identifier application number: M012
GOOD NEIGHBOR PHARMACY DAYTIME FLU RELIEF MAX STRENGTH	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	AMERISOURCE BERGEN	45dc9dd7-134a-4e70-a07e-7bfdf0dc1c4e	2026-05-21	Warnings	Exact identifier application number: M012
Extra Strength Tylenol Cold plus Flu Multi-Symptom Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Kenvue Brands LLC	525467fb-510d-0b4b-e063-6294a90acd36	2026-05-21	Warnings	Exact identifier application number: M012
Mucinex Childrens	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL	Reckitt Benckiser LLC	4cee80e5-e412-e832-e063-6394a90aeb90	2026-05-21	Warnings	Exact identifier application number: M012
Mucinex Childrens Multi-Symptom Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	Reckitt Benckiser LLC	4a9464cf-0c77-23d0-e063-6394a90a62f1	2026-05-21	Warnings	Exact identifier application number: M012
Mucinex Childrens Night Time Multi-Symptom Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL	Reckitt Benckiser LLC	4ceda68e-c7ce-eb87-e063-6394a90a8ded	2026-05-21	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold and Sinus Maximum Strength Day Night Fast Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	5258ea3f-87f1-7f86-e063-6394a90ab82f	2026-05-21	Warnings	Exact identifier application number: M012
RELIABLE-1 ANTI DRIP PUMP MIST	OXYMETAZOLINE HYDROCHLORIDE	Reliable 1 Laboratories LLC	7df9905d-09aa-4c84-8b6f-6e5ed90df0da	2026-05-21	Warnings	Exact identifier application number: M012
daytime nitetime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Publix Super Markets Inc	80abb6b8-b0d5-4f19-8588-50b8717510bb	2026-05-21	Warnings	Exact identifier application number: M012
FAMILY DOLLAR ULTRA FINE MIST SINUS RELIEF	OXYMETAZOLINE HYDROCHLORIDE	FAMILY DOLLAR SERVICES INC	27163169-54d0-4b6e-94cd-721b29b18249	2026-05-20	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold and Cough Fast	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Bayer HealthCare LLC.	5241b11a-72c8-5e67-e063-6394a90a4353	2026-05-20	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Cold, Flu and Sore Throat	ACETAMINOPHEN, GUAIFENESIN	Reckitt Benckiser LLC	50b140ad-aba2-ce6b-e063-6294a90ae2f8	2026-05-20	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Recharge Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	4bae240c-70ce-e9c2-e063-6394a90a5f3d	2026-05-20	Warnings	Exact identifier application number: M012
Childrens Mucinex Multi Symptom Cold and Childrens Mucinex Night Time Multi Symptom Cold	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	85f7d60b-32ec-4ec2-86ec-f677093bce1d	2026-05-20	Warnings	Exact identifier application number: M012
Chloraseptic Nighttime Sore Throat Hot Relief	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	Prestige Brands Holdings, Inc.	9c13c052-a5d1-43d2-8d29-4ea011a971ac	2026-05-20	Warnings	Exact identifier application number: M012
Cold and Flu Severe, Daytime, Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Rite Aid Corporation	a0bff310-2d35-4a18-815b-8386e44730a2	2026-05-19	Warnings	Exact identifier application number: M012
equate nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	WALMART INC.	61a1beb3-decf-4c8d-a402-93a02ec40a43	2026-05-19	Warnings	Exact identifier application number: M012
Extra Strength Tylenol Cold plus Flu Multi-Symptom Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Kenvue Brands LLC	52291746-2bbf-8f3f-e063-6294a90adcfc	2026-05-19	Warnings	Exact identifier application number: M012
MUCINEX FAST MAX Liquid Cold and Flu Kickstart and MUCINEX Nightshift Kickstart	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, TRIPROLIDINE HCI	Reckitt Benckiser LLC	fdb70793-5dd1-0455-e053-6394a90ac621	2026-05-19	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Severe Congestion and Cough	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Reckitt Benckiser LLC	3270f369-7a40-186d-e063-6394a90a8526	2026-05-19	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