FDA.reportPublic FDA data

Medique Diphen

Product NDC
47682-167
11-digit product format
476820167
Labeler code
47682
Product ID
47682-167_3e4c2097-aa05-fa04-e063-6394a90afe56
Type
HUMAN OTC DRUG
Nonproprietary name
DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unifirst First Aid Corporation
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-01-01
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

Additional Listing Data#

Finished product
Yes
Brand name base
Medique Diphen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1049630

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
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4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313
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0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
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874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
ac6963c4-31c6-325f-ee58-83a0a06597adProduct name520221206
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
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06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
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103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
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3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
377068df-225f-7318-a910-a1987cdfa361Product name320170608
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
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182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47682-167-32Medique Diphen12 in 1 BOXTABLET, FILM COATED1216
47682-167-32Medique Diphen1 in 1 PACKETTABLET, FILM COATED116
47682-167-46Medique Diphen1 in 1 PACKETTABLET, FILM COATED116
47682-167-47Medique Diphen200 in 1 BOXTABLET, FILM COATED20016
47682-167-64Medique Diphen1 in 1 PACKETTABLET, FILM COATED116
47682-167-64Medique Diphen24 in 1 BOXTABLET, FILM COATED2416

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40MEDIQUE DIPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]3
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MMEDIQUE DIPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]3
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZMEDIQUE DIPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMEDIQUE DIPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MEDIQUE DIPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]3
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KMEDIQUE DIPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]3
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPMEDIQUE DIPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMEDIQUE DIPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]3
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GMEDIQUE DIPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MEDIQUE DIPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]3
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AMEDIQUE DIPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HMEDIQUE DIPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MEDIQUE DIPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMEDIQUE DIPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47682-167MEDIQUE DIPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]15Current NDC, Legacy NDC, 6 package rows20241120_b61ee2e0-2543-447d-9fc4-23363d46ce04.zip
47682-167CARE SCIENCE OSHA FIRST AID (ETHYL ALCOHOL, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN-B SULFATE, DIPHENHYDRAMINE HYDROCHLORIDE, HYDROCORTISONE, IBUPROFEN, ACETAMINOPHEN, WATER) KIT [ASO LLC]2Current NDC, Legacy NDC20241107_1cbace4d-fd0a-41d1-aa71-907d43620bf8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSNb61ee2e0-2543-447d-9fc4-23363d46ce0416
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCDb61ee2e0-2543-447d-9fc4-23363d46ce0416
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN44217a8c-7656-a0f6-e063-6294a90af2ad3
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD44217a8c-7656-a0f6-e063-6294a90af2ad3
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN5e31b1ff-291f-7b8c-e053-2a91aa0aedbc2
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD5e31b1ff-291f-7b8c-e053-2a91aa0aedbc2
313782acetaminophen 325 MG Oral TabletPSN4feee16b-43be-bb71-e063-6394a90af9591
313782acetaminophen 325 MG Oral TabletPSN522da86b-cfd7-dd20-e063-6394a90a51c61
153008Advil 200 MG Oral TabletPSN4feee16b-43be-bb71-e063-6394a90af9591
1536680Alka-Seltzer 325 MG / 1000 MG / 1916 MG Effervescent Oral TabletPSN4feee16b-43be-bb71-e063-6394a90af9591
1536675aspirin 325 MG / citric acid 1000 MG / sodium bicarbonate 1916 MG Effervescent Oral TabletPSN4feee16b-43be-bb71-e063-6394a90af9591
2606079aspirin 325 MG Effervescent Oral TabletPSN522da86b-cfd7-dd20-e063-6394a90a51c61
212033aspirin 325 MG Oral TabletPSN4feee16b-43be-bb71-e063-6394a90af9591
212033aspirin 325 MG Oral TabletPSN522da86b-cfd7-dd20-e063-6394a90a51c61
308761bismuth subsalicylate 262 MG Chewable TabletPSN4feee16b-43be-bb71-e063-6394a90af9591
308761bismuth subsalicylate 262 MG Chewable TabletPSN522da86b-cfd7-dd20-e063-6394a90a51c61
313884calcium carbonate 420 MG (Ca 168 MG) Chewable TabletPSN522da86b-cfd7-dd20-e063-6394a90a51c61
313884calcium carbonate 420 MG (Ca 168 MG) Chewable TabletPSN4feee16b-43be-bb71-e063-6394a90af9591
978012Diamode 2 MG Oral TabletPSN522da86b-cfd7-dd20-e063-6394a90a51c61
978012Diamode 2 MG Oral TabletPSN4feee16b-43be-bb71-e063-6394a90af9591
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN4feee16b-43be-bb71-e063-6394a90af9591
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN522da86b-cfd7-dd20-e063-6394a90a51c61
310965ibuprofen 200 MG Oral TabletPSN522da86b-cfd7-dd20-e063-6394a90a51c61
310965ibuprofen 200 MG Oral TabletPSN4feee16b-43be-bb71-e063-6394a90af9591
978010loperamide HCl 2 MG Oral TabletPSN522da86b-cfd7-dd20-e063-6394a90a51c61
978010loperamide HCl 2 MG Oral TabletPSN4feee16b-43be-bb71-e063-6394a90af9591
1020126Loradamed 10 MG 24HR Oral TabletPSN522da86b-cfd7-dd20-e063-6394a90a51c61
1020126Loradamed 10 MG 24HR Oral TabletPSN4feee16b-43be-bb71-e063-6394a90af9591
311372loratadine 10 MG 24HR Oral TabletPSN4feee16b-43be-bb71-e063-6394a90af9591
311372loratadine 10 MG 24HR Oral TabletPSN522da86b-cfd7-dd20-e063-6394a90a51c61
995666meclizine HCl 25 MG Oral TabletPSN4feee16b-43be-bb71-e063-6394a90af9591
995666meclizine HCl 25 MG Oral TabletPSN522da86b-cfd7-dd20-e063-6394a90a51c61
211151Pepto-Bismol 262 MG Chewable TabletPSN4feee16b-43be-bb71-e063-6394a90af9591
1049182phenylephrine HCl 10 MG Oral TabletPSN4feee16b-43be-bb71-e063-6394a90af9591
1049182phenylephrine HCl 10 MG Oral TabletPSN522da86b-cfd7-dd20-e063-6394a90a51c61
1536680aspirin 325 MG / citric acid 1000 MG / sodium bicarbonate 1916 MG Effervescent Oral Tablet [Alka-Seltzer]SBD4feee16b-43be-bb71-e063-6394a90af9591
211151bismuth subsalicylate 262 MG Chewable Tablet [Pepto-bismol]SBD4feee16b-43be-bb71-e063-6394a90af9591
153008ibuprofen 200 MG Oral Tablet [Advil]SBD4feee16b-43be-bb71-e063-6394a90af9591
978012loperamide hydrochloride 2 MG Oral Tablet [Diamode]SBD4feee16b-43be-bb71-e063-6394a90af9591
978012loperamide hydrochloride 2 MG Oral Tablet [Diamode]SBD522da86b-cfd7-dd20-e063-6394a90a51c61
1020126loratadine 10 MG Oral Tablet [Loradamed]SBD522da86b-cfd7-dd20-e063-6394a90a51c61
1020126loratadine 10 MG Oral Tablet [Loradamed]SBD4feee16b-43be-bb71-e063-6394a90af9591
313782acetaminophen 325 MG Oral TabletSCD522da86b-cfd7-dd20-e063-6394a90a51c61
313782acetaminophen 325 MG Oral TabletSCD4feee16b-43be-bb71-e063-6394a90af9591
1536675aspirin 325 MG / citric acid 1000 MG / sodium bicarbonate 1916 MG Effervescent Oral TabletSCD4feee16b-43be-bb71-e063-6394a90af9591
2606079aspirin 325 MG Effervescent Oral TabletSCD522da86b-cfd7-dd20-e063-6394a90a51c61
212033aspirin 325 MG Oral TabletSCD522da86b-cfd7-dd20-e063-6394a90a51c61
212033aspirin 325 MG Oral TabletSCD4feee16b-43be-bb71-e063-6394a90af9591
308761bismuth subsalicylate 262 MG Chewable TabletSCD4feee16b-43be-bb71-e063-6394a90af9591
308761bismuth subsalicylate 262 MG Chewable TabletSCD522da86b-cfd7-dd20-e063-6394a90a51c61
313884calcium carbonate 420 MG Chewable TabletSCD522da86b-cfd7-dd20-e063-6394a90a51c61
313884calcium carbonate 420 MG Chewable TabletSCD4feee16b-43be-bb71-e063-6394a90af9591
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD522da86b-cfd7-dd20-e063-6394a90a51c61
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD4feee16b-43be-bb71-e063-6394a90af9591
310965ibuprofen 200 MG Oral TabletSCD522da86b-cfd7-dd20-e063-6394a90a51c61
310965ibuprofen 200 MG Oral TabletSCD4feee16b-43be-bb71-e063-6394a90af9591
978010loperamide hydrochloride 2 MG Oral TabletSCD522da86b-cfd7-dd20-e063-6394a90a51c61
978010loperamide hydrochloride 2 MG Oral TabletSCD4feee16b-43be-bb71-e063-6394a90af9591
311372loratadine 10 MG Oral TabletSCD4feee16b-43be-bb71-e063-6394a90af9591
311372loratadine 10 MG Oral TabletSCD522da86b-cfd7-dd20-e063-6394a90a51c61
995666meclizine hydrochloride 25 MG Oral TabletSCD4feee16b-43be-bb71-e063-6394a90af9591
995666meclizine hydrochloride 25 MG Oral TabletSCD522da86b-cfd7-dd20-e063-6394a90a51c61
1049182phenylephrine hydrochloride 10 MG Oral TabletSCD4feee16b-43be-bb71-e063-6394a90af9591
1049182phenylephrine hydrochloride 10 MG Oral TabletSCD522da86b-cfd7-dd20-e063-6394a90a51c61
153008Advil 200 MG Oral TabletSY4feee16b-43be-bb71-e063-6394a90af9591
1536680Alka-Seltzer (aspirin 325 MG / citric acid 1000 MG / sodium bicarbonate 1916 MG) Effervescent Oral TabletSY4feee16b-43be-bb71-e063-6394a90af9591
313782APAP 325 MG Oral TabletSY4feee16b-43be-bb71-e063-6394a90af9591
313782APAP 325 MG Oral TabletSY522da86b-cfd7-dd20-e063-6394a90a51c61
1536675ASA 325 MG / Citric Acid 1000 MG / NaHCO3 1916 MG Effervescent Oral TabletSY4feee16b-43be-bb71-e063-6394a90af9591
1536680ASA 325 MG / Citric Acid 1000 MG / NaHCO3 1916 MG Effervescent Oral Tablet [Alka-Seltzer]SY4feee16b-43be-bb71-e063-6394a90af9591
2606079ASA 325 MG Effervescent Oral TabletSY522da86b-cfd7-dd20-e063-6394a90a51c61
212033ASA 325 MG Oral TabletSY4feee16b-43be-bb71-e063-6394a90af9591
212033ASA 325 MG Oral TabletSY522da86b-cfd7-dd20-e063-6394a90a51c61
313884calcium carbonate 420 MG (calcium 168 MG) Chewable TabletSY4feee16b-43be-bb71-e063-6394a90af9591
313884calcium carbonate 420 MG (calcium 168 MG) Chewable TabletSY522da86b-cfd7-dd20-e063-6394a90a51c61
978012Diamode 2 MG Oral TabletSY522da86b-cfd7-dd20-e063-6394a90a51c61
978012Diamode 2 MG Oral TabletSY4feee16b-43be-bb71-e063-6394a90af9591
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY522da86b-cfd7-dd20-e063-6394a90a51c61
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY4feee16b-43be-bb71-e063-6394a90af9591
1020126Loradamed 10 MG Oral TabletSY522da86b-cfd7-dd20-e063-6394a90a51c61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47682-167-324768201673212 in 1 BOXHistorical
47682-167-46476820167461 TABLET, FILM COATED in 1 PACKET (47682-167-46) 2012-01-010000-00-00NoNoCurrent
47682-167-4747682016747200 PACKET in 1 BOX (47682-167-47) / 1 TABLET, FILM COATED in 1 PACKET (47682-167-46) 200 packet2012-01-010000-00-00NoNoCurrent
47682-167-644768201676424 PACKET in 1 BOX (47682-167-64) / 1 TABLET, FILM COATED in 1 PACKET24 packet2012-01-010000-00-00NoNoCurrent