Home NDC 57243-235 Pain Reliever PM
Product NDC 57243-235
11-digit product format 572430235
Labeler code 57243
Product ID 57243-235_ac1496d2-7b9e-468f-acdf-607a6efd98e8
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Diphenhydramine HCl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Salado Sales, Inc.
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 1994-05-15
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 Reliever 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 57243-235-15 Pain Reliever PMExtra Strength 1 in 1 CARTON TABLET, FILM COATED 1 14 57243-235-15 Pain Reliever PMExtra Strength 50 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 50 14
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SALADO SALES, INC.] 2 DIPHENHYDRAMINE HYDROCHLORIDE ACTIVE INGREDIENT TC2D6JAD40 PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SALADO SALES, INC.] 2 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SALADO SALES, INC.] 2 DIPHENHYDRAMINE ACTIVE MOIETY 8GTS82S83M PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SALADO SALES, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SALADO SALES, INC.] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SALADO SALES, INC.] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SALADO SALES, INC.] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SALADO SALES, INC.] 2 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SALADO SALES, INC.] 2 POVIDONES INACTIVE INGREDIENT FZ989GH94E PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SALADO SALES, INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SALADO SALES, INC.] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SALADO SALES, INC.] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SALADO SALES, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SALADO SALES, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57243-235 PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SALADO SALES, INC.] 13 Current NDC, Legacy NDC, 2 package rows 20240825_aef30709-f33d-48ff-b2d4-0639ffbd1ffd.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 57243-235-15 57243023515 1 BOTTLE, PLASTIC in 1 CARTON (57243-235-15) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 1994-05-15 0000-00-00 No No Current