Home NDC 55910-655 Pain Relief PM
Product NDC 55910-655
11-digit product format 559100655
Labeler code 55910
Product ID 55910-655_576227a6-39d3-4f42-b52f-261ad038c632
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen and Diphenhydramine HCl
Dosage form TABLET, COATED
Route ORAL
Labeler DOLGENCORP, LLC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2007-12-17
Substance ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 500; 25 mg/1; 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 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 Pain Relief PM
Brand name suffix Extra Strength
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 500 mg/1 DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup 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 1092189 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55910-655-10 Pain Relief PMExtra Strength 1 in 1 CARTON TABLET, COATED 1 16 55910-655-10 Pain Relief PMExtra Strength 40 in 1 BOTTLE, PLASTIC TABLET, COATED 40 16 55910-655-31 Pain Relief PMExtra Strength 80 in 1 BOTTLE, PLASTIC TABLET, COATED 80 16 55910-655-31 Pain Relief PMExtra Strength 1 in 1 CARTON TABLET, COATED 1 16
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [DOLGENCORP, LLC] 3 DIPHENHYDRAMINE HYDROCHLORIDE ACTIVE INGREDIENT TC2D6JAD40 PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [DOLGENCORP, LLC] 3 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [DOLGENCORP, LLC] 3 DIPHENHYDRAMINE ACTIVE MOIETY 8GTS82S83M PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [DOLGENCORP, LLC] 3 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [DOLGENCORP, LLC] 3 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [DOLGENCORP, LLC] 3 FD&C RED NO. 3 INACTIVE INGREDIENT PN2ZH5LOQY PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [DOLGENCORP, LLC] 3 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [DOLGENCORP, LLC] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [DOLGENCORP, LLC] 3 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [DOLGENCORP, LLC] 3 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [DOLGENCORP, LLC] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [DOLGENCORP, LLC] 3 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [DOLGENCORP, LLC] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [DOLGENCORP, LLC] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55910-655 PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET, COATED [DOLGENCORP, LLC] 15 Current NDC, Legacy NDC, 4 package rows 20250416_8e65478b-7a7b-416c-b8e3-23dad79f8cc1.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 76 of 79 · 1,576 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Acetaminophen Extra Strength ACETAMINOPHEN Aurohealth LLC 03d42892-4465-4089-90a7-cd5f00c35602 2023-11-29 Warnings Exact identifier application number: M013 Acetaminophen Extra Strength ACETAMINOPHEN Aurohealth LLC 57bb1acc-b9a0-48cd-8e5c-33712441ce81 2023-11-29 Warnings Exact identifier application number: M013 Acetaminophen Regular Strength ACETAMINOPHEN Aurohealth LLC cc0ab7a1-e535-4dc8-962f-c58949fc1737 2023-11-29 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Aurohealth LLC a4ff94b9-c248-4cd3-8491-38e9555cc22e 2023-11-29 Warnings Exact identifier application number: M013 Aurophen Extra Strength for Adults ACETAMINOPHEN Aurohealth LLC d59c5f04-4bcc-4a52-a42f-e049506f00de 2023-11-29 Warnings Exact identifier application number: M013 Aurophen Extra Strength for Adults ACETAMINOPHEN Aurohealth LLC a769094b-1e91-4ca7-ba67-21aa7e312910 2023-11-29 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Aurohealth LLC 30756257-f748-4a5d-b031-dd267d0f91ad 2023-11-29 Warnings Exact identifier application number: M013 Aurophen Regular Strength ACETAMINOPHEN Aurohealth LLC 8eda893f-5266-4b7a-95b9-2e194973cf06 2023-11-29 Warnings Exact identifier application number: M013 Childrens Pain Relief ACETAMINOPHEN Aurohealth LLC 00ec6518-b5e3-49d1-a342-139381c3bfd2 2023-11-29 Warnings Exact identifier application number: M013 CHILDRENS PAIN RELIEF ACETAMINOPHEN Better Living Brands, LLC fadb4c09-071f-56c0-e053-6294a90ae6c1 2023-11-28 Warnings Exact identifier application number: M013 Acetaminophen and Diphenhydramine hydrochloride ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE Better Living Brands, LLC fc07d516-9ffe-9989-e053-6294a90ae1a5 2023-11-28 Warnings Exact identifier application number: M013 NOTTS - Tension Headache ACETAMINOPHEN, CAFFEINE VIVUNT PHARMA LLC 08f2ae03-967b-ad7e-e063-6294a90a8484 2023-11-24 Warnings Exact identifier application number: M013 Sanatos Multi Symptoms Nighttime ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE Pharmadel LLC 0a60326a-a17b-e843-e063-6394a90ac211 2023-11-22 Warnings Exact identifier application number: M013 Sanatos Nighttime Multi Symptoms ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE Pharmadel LLC 0ab188f3-f7f9-d665-e063-6294a90a198a 2023-11-22 Warnings Exact identifier application number: M013 ASPIRIN ASPIRIN TIME CAP LABS INC fe12519c-3e5f-4592-bd34-2d6b81b981f4 2023-11-22 Warnings Exact identifier application number: M013 Rugby Regular Strength Acetaminophen ACETAMINOPHEN A-S Medication Solutions 400d4a29-9e39-4e74-8272-37be5d789924 2023-11-22 Warnings Exact identifier application number: M013 RIGHT REMEDIES Pain Relief Extra Strength Caplet ACETAMINOPHEN Strive Pharmaceuticals Inc. dcce28d9-8528-489e-b995-1d98e9d0e6ad 2023-11-21 Warnings Exact identifier application number: M013 Sanatos Multi Symptom Daytime ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI Pharmadel LLC 0ab11691-5b29-55fc-e063-6394a90aa328 2023-11-17 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN A-S Medication Solutions 1e223faa-f6d0-4235-bc4c-6cfca84a5b0a 2023-11-17 Warnings Exact identifier application number: M013 SanaTos X ACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN, PHENYLEPHRINE HCI Pharmadel LLC 85b8ef3d-7318-7f3b-e053-2991aa0a0777 2023-11-14 Warnings Exact identifier application number: M013
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 55910-655-10 55910065510 1 BOTTLE, PLASTIC in 1 CARTON (55910-655-10) / 40 TABLET, COATED in 1 BOTTLE, PLASTIC 2007-12-17 0000-00-00 No No Current 55910-655-31 55910065531 1 BOTTLE, PLASTIC in 1 CARTON (55910-655-31) / 80 TABLET, COATED in 1 BOTTLE, PLASTIC 2007-12-17 0000-00-00 No No Current